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 2020-02-13 for UNK - CABLE/WIRE ACCESSORIES: ORTHOPAEDIC CABLE manufactured by Wrights Lane Synthes Usa Products Llc.
[180802073]
Complainant part is not expected to be returned for manufacturer review/ investigation. This report is for an unknown cable/ wire accessories: orthopaedic cable/ unknown lot. Part and lot number are unknown. Without the specific part number; the udi number and 510-k number is unknown. (b)(4). Without a lot number the device history records review could not be completed. Product was not returned. 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
[180802094]
It was reported that on an unknown date, the patient underwent hardware removal and conversion to total hip due to trochanteric fixation nail advanced (tfna) lag screw that cut out of the femoral head. All hardware was removed easily. The lag screw was pulled out without disengaging the built in locking mechanism. Upon removal, it did not appear any hardware was broken. The infection has not been ruled out. Many tissue samples and hardware samples were sent for evaluation within the hospital pathology department. The procedure and patient outcomes are unknown. Concomitant devices reported: tfna nail (part # unknown, lot # unknown, quantity unknown), end caps (part # unknown, lot # unknown, quantity unknown), locking screw (part # unknown, lot # unknown, quantity unknown), lag screw (part # unknown, lot # unknown, quantity unknown). This report is for one (1) unknown cable/ wire accessories: orthopaedic cable. This is report 5 of 5 for complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2939274-2020-00816 |
| MDR Report Key | 9707221 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-13 |
| 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 ACCESSORIES: ORTHOPAEDIC CABLE |
| Generic Name | WIRE, SURGICAL |
| Product Code | LRN |
| Date Received | 2020-02-13 |
| 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 | 2020-02-13 |