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 2020-01-13 for UNK - CABLE/WIRE: ORTHOPAEDIC CABLE manufactured by Wrights Lane Synthes Usa Products Llc.
[186303681]
This report is for an unknown cable/wire: orthopaedic cable/unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. (b)(4). 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. 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
[186303682]
It was reported that on (b)(6) 2019, one (1) trochanteric femoral nail, one (1) helical blade, one (1) unknown locking screw, and one (1) unknown cable wire were removed due to nonunion. The patient had a tumor in the proximal femur. The femur was resected and a total hip was done. All hardware came out successfully. It is unknown if there was surgical delay. Procedure outcome was unknown. There was no patient consequence. This report is for one (1) unknown cable/wire: orthopaedic cable this is report 4 of 4 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00155 |
| MDR Report Key | 9582584 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-13 |
| Date of Report | 2019-12-18 |
| Date Mfgr Received | 2020-01-24 |
| Date Added to Maude | 2020-01-13 |
| 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 | 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 - CABLE/WIRE: ORTHOPAEDIC CABLE |
| Generic Name | WIRE, SURGICAL |
| Product Code | LRN |
| Date Received | 2020-01-13 |
| 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 | 1. Required No Informationntervention | 2020-01-13 |