MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-08-27 for MEDIUM AWL FOR FLEXIBLE HUMERAL NAIL 351.019 manufactured by Wrights Lane Synthes Usa Products Llc.
[118405665]
Patient information was not provided for reporting. Gtin unavailable, product made prior to gtin compliance date. Device is an instrument and is not implanted / explanted. Device is not expected to be returned for manufacturer review/investigation. Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer. Additionally, device history records review has been requested. 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
[118405666]
It was reported that during an unknown case on (b)(6) 2018 the tip of the awl broke. The tip of the broken device was retrieved from the patient. It is unknown if there was a surgical delay. Patient outcome was unknown. The surgery was completed. This report is for one (1) medium awl for flexible humeral nail. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2018-53488 |
| MDR Report Key | 7819303 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-08-27 |
| Date of Report | 2018-08-08 |
| Date of Event | 2018-08-07 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2003-12-30 |
| Date Added to Maude | 2018-08-27 |
| 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 | MICHAEL COTE |
| Manufacturer Street | 1302 WRIGHT LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Manufacturer G1 | BRANDYWINE |
| Manufacturer Street | 1303 GOSHEN PARKWAY |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19380 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIUM AWL FOR FLEXIBLE HUMERAL NAIL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2018-08-27 |
| Catalog Number | 351.019 |
| Lot Number | 4663868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2018-08-27 |