MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-09-19 for 2.7MM CORTEX SCREW SELF-TAPPING 30MM 202.830 manufactured by Wrights Lane Synthes Usa Products Llc.
[120823487]
Date of event is unknown. Additional product code: hwc. Exp. Date is unknown. Complainant device is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. The investigation could not be completed; no conclusion could be drawn, as no product was received. Device was used for treatment, not diagnosis. Based on the information available, it has been determined that no corrective and preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. 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
[120823488]
It was reported that a patient underwent a hardware removal surgery due to wound breakdown on (b)(6) 2018. Four (4) self tapping metaphyseal screws, four (4) variable angle (va) self tapping locking screws, one (1) va large locking calcaneal plate, one (1) self tapping cortex screw were removed. One (1) self tapping cortex screw remained implanted due to unknown reason. Original implant date is on (b)(6) 2018. Patient status is unknown. The procedure was completed successfully. This report is 7 of 10 for (b)(4). This complaint involves ten (10) devices.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53871 |
| MDR Report Key | 7891844 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-09-19 |
| Date of Report | 2018-08-29 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2018-09-19 |
| 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 | MR. 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 | MONUMENT |
| Manufacturer Street | 1101 SYNTHES AVENUE |
| Manufacturer City | MONUMENT CO 80132 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 2.7MM CORTEX SCREW SELF-TAPPING 30MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2018-09-19 |
| Model Number | 202.830 |
| Catalog Number | 202.830 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHTS LANE SYNTHES USA PRODUCTS LLC |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-19 |