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 2020-03-29 for UNK - NAIL HEAD ELEM: TFN LAG SCREW manufactured by Wrights Lane Synthes Usa Products Llc.
[185541420]
Product complaint#: (b)(4). This report is for an unknown - nail head elem: tfn lag screw/unknown lot number. Without the specific part number, the udi number and 510k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number, the device history records review could not be completed as no product was received. Investigation summary: product was not returned. Based on the information available, it has been determined that no corrective and preventive action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. 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
[185541421]
It was reported that on an unknown date, the surgeon could not insert the unknown lag screw into the unknown titanium trochanteric fixation nail (tfn) nail. There was a surgical delay. The procedure was successfully completed. The patient outcome was fine. This complaint involves two devices. This report is for one unk - nail head elem: tfn lag screw. This report is 2 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01577 |
| MDR Report Key | 9895009 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-29 |
| Date of Report | 2020-02-29 |
| Date Mfgr Received | 2020-02-29 |
| Date Added to Maude | 2020-03-29 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNK - NAIL HEAD ELEM: TFN LAG SCREW |
| Generic Name | ROD, FIXATION, INTRAMEDULLARY |
| Product Code | HSB |
| Date Received | 2020-03-29 |
| Catalog Number | UNK - NAIL HEAD ELEM: TFN LAG |
| 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 | 2020-03-29 |