MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-24 for UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION manufactured by Wrights Lane Synthes Usa Products Llc.
[186113505]
Product complaint # (b)(4). This report is for an unknown - nail head elements: fns bolt/ unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. Reporter is a synthes rep. Without a lot number the device history records review could not be completed. Product was not returned. The investigation could not be completed; no conclusion could be drawn, as no product was received. (b)(4). 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
[186113506]
Device report from synthes reports an event in (b)(6) as follows: it was reported that the patient underwent the removal of an unknown femoral neck system implant due to unknown reasons on (b)(6) 2020. Patient had osteopenic bone, which lead to implant failure. Patient received a revision hip. The initial surgery was on (b)(6) 2020. The procedure outcome is unknown however, the patient is doing well. This complaint involves unknown number of devices. This report is for one (1) unk - nail head elements: fns anti-rotation. This report is 3 of 3 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-01502 |
| MDR Report Key | 9875130 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-01 |
| Date Mfgr Received | 2020-02-26 |
| Date Added to Maude | 2020-03-24 |
| 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 ELEMENTS: FNS ANTIROTATION |
| Generic Name | NAIL, FIXATION, BONE |
| Product Code | JDS |
| Date Received | 2020-03-24 |
| Catalog Number | UNK - NAIL HEAD ELEMENTS: FNS |
| 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 | 2020-03-24 |