MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-20 for APPLIANCE, FIXATION, NAIL/BLADE manufactured by Synthes Usa.
[89925419]
This report is for unk - pfna head element/unknown lot number. Portion of the device is still implanted in the patient, not explanted. Device is not expected to be returned for manufacturer review/investigation. (b)(6). Patient code (b)(4) used for: the complainant indicated that the extraction screw is stuck in the implanted blade and the blade was unable to be explanted. Therefore, a non-implant grade fragment is retained in the patient. Without a lot number, the device history record review and the investigation could not be completed; no conclusion could be drawn, as no product was not returned and no lot number was provided. Based on the information available, this complaint will be accounted for and monitored via post market surveillance activities. If additional is obtained that was not available for the initial med-watch, the investigation will be updated as applicable, and a follow-up med-watch will be filed as appropriate. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[89925420]
Device report from synthes on an event in (b)(6) as follows: it was reported that the nurse called the sales rep on (b)(6)17 and told him that they have problems during the surgery. They were about to remove a proximal femoral antirotation blade (pfna) and had accidently used a wrong guide wire and when the used the extraction screw, the tip broke into the pfna blade. The blade could not be removed, and they tried to get it out. The sales rep suggested to organize an instrument set for pfna blade removal but the nurse said that this would take too long time. The nurse would talk to the surgeon, and would return if they needed the instrument set for pfna blade removal. The sales rep did not heard from them. The surgery was prolonged to an unknown time. No information available about patient condition and outcome. It was reported that the patient had post-operativey pain and thought this was because of the implanted proximal femoral antirotation (pfna) implants ((b)(4)). They could not remove the implant, and have closed the site, and will now plan and order instrument for removal of damaged pfna blade. The blade is still in the patient. The broken off piece of the extraction screw is stuck in the implanted blade. The surgery was not successfully completed. This complaint involves 2 parts. Concomitant reported parts:1x unknown guide wire (? 2,5 or 2,8 mm)this report is 2 of 2 for com-323699
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2520274-2017-12492 |
| MDR Report Key | 6966815 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-20 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-10-02 |
| Date Mfgr Received | 2018-05-22 |
| Device Manufacturer Date | 2014-08-19 |
| Date Added to Maude | 2017-10-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | WERK BETTLACH (CH) |
| Manufacturer Street | MURACHERSTRASSE 3 |
| Manufacturer City | BETTLACH 2544 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 2544 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | APPLIANCE, FIXATION, NAIL/BLADE |
| Product Code | KTW |
| Date Received | 2017-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES USA |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-20 |