MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-10 for UNK - GUIDE/COMPRESSION/K-WIRES manufactured by Oberdorf Synthes Produktions Gmbh.
[182967423]
This report is for an unknown k-wire/ unknown lot. Part and lot number are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/ investigation. The investigation could not be completed; no conclusion could be drawn, as no product was received. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. (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
[182967424]
Device report from the (b)(6) reports an event as follows: it was reported that on (b)(6) 2020, a long trochanteric fixation nail advanced (rfna) was inserted with a lag blade in the femoral head and distal locking was completed. On viewing the final x-rays, it was discovered the lag blade had missed the nail. This was subsequently removed, the jig and handle were reconnected, and a new blade was inserted. Concomitant devices: locking screw (part: 04. 005. 528s, lot: unknown, quantity: 1), locking screw (part: 04. 005. 530s, lot: unknown, quantity: 1), tfna nail (part: 04. 037. 228s, lot: 14l5269, quantity: 1), tfna helical blade (part: 04. 038. 390s, lot: 10l0160, quantity: 1), guide (part: unknown, lot: unknown, quantity: 1), insertion handle (part: unknown, lot: unknown, quantity: unknown). This report is for an unknown k-wire. This is report 4 of 5 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030965-2020-01774 |
| MDR Report Key | 9812688 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-10 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-10 |
| 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 - GUIDE/COMPRESSION/K-WIRES |
| Generic Name | GUIDE |
| Product Code | FZX |
| Date Received | 2020-03-10 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OBERDORF SYNTHES PRODUKTIONS GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 OBERDORF 4436 SZ 4436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-10 |