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 2020-03-06 for 14.0MM CANNULATED AWL 03.010.041 manufactured by Wrights Lane Synthes Usa Products Llc.
[188860183]
(b)(4). 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
[188860184]
It was reported that during an intramedullary (im) nailing of the femur for rotational osteotomy of the femur on (b)(6) 2020, while getting the starting point in the femur for im nail, the tip of the cannulated awl broke off. It took about 30-40 minutes to retrieved the broken piece out of the patient as the surgeon had to make a larger incision in order to access the piriformis fossa where the fragment was lodge. The procedure was successfully completed with the use of an opening reamer. Patient status was unknown. Concomitant device reported: unknown guidewire (part # unknown, lot # unknown, quantity 1). This report is for one (1) 14. 0mm cannulated awl. This is report 1 of 1 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01164 |
| MDR Report Key | 9799810 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-06 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-10 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2006-05-10 |
| Date Added to Maude | 2020-03-06 |
| 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 | 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 H |
| Manufacturer Street | IM BIFANG 6 |
| Manufacturer City | HAEGENDORF 4614 |
| Manufacturer Country | SZ |
| Manufacturer Postal Code | 4614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 14.0MM CANNULATED AWL |
| Generic Name | AWL |
| Product Code | HWJ |
| Date Received | 2020-03-06 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 03.010.041 |
| Catalog Number | 03.010.041 |
| Lot Number | 1493547 |
| 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 | 1. Required No Informationntervention | 2020-03-06 |