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 2019-03-01 for 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM 241.901 manufactured by Wrights Lane Synthes Usa Products Llc.
[137839565]
The device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. 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
[137839566]
It was reported that during an open reduction internal fixation (orif) surgery on (b)(6) 2019, the locking compression plate (lcp) proximal humerus plate, was unable to thread any of the insertion guides into the proximal portion of the plate. A new plate was used for the fracture fixation. The procedure was successfully completed with a thirty (30) minutes of surgical delay. Patient status is unknown. Concomitant devices reported: insertion guide (part# 323. 050, lot# unknown, quality: unknown). This report is for one (1) 3. 5mm lcp proximal humerus plate. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2019-56764 |
| MDR Report Key | 8382846 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-07 |
| Date of Event | 2019-02-07 |
| Date Mfgr Received | 2019-03-27 |
| Device Manufacturer Date | 2018-10-25 |
| Date Added to Maude | 2019-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KARA DITTY-BOVARD |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6103142063 |
| Manufacturer G1 | WERK RARON (CH) |
| Manufacturer Street | KANALSTRASSE WEST 30 |
| Manufacturer City | RARON 3942 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 3942 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3.5MM LCP? PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM |
| Generic Name | APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT |
| Product Code | KTW |
| Date Received | 2019-03-01 |
| Returned To Mfg | 2019-02-21 |
| Model Number | 241.901 |
| Catalog Number | 241.901 |
| Lot Number | 1L76920 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-03-01 |