MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - NAILS: TFNA ROD, FIXATION, INTRAMEDULLARY

Catalog Number UNK - NAILS: TFNA

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Additional narrative: 510k: this report is for an unknown nails: tfna/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Initial reporter is a j&j employee. (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. 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. Investigation summary: the photo was returned to depuy synthes for evaluation. The depuy synthes team conducted a visual inspection of the returned device from attachment ((b)(4) litigation records ad 24 mar 2022). On visual inspection of the provided image of the unk - nails: tfna, no observations could be made due to the poor image quality. As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed. As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications. The overall complaint was not confirmed for unk - nails: tfna. There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined. Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed. Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

Event Description

Device report from synthes reports an event in the usa as follows: it was reported that on (b)(6) 2020, patient had a comminuted intertrochanteric hip fracture and was implanted with tfna device. On (b)(6) 2020, patient undergone unnecessary explant and revision surgery. A photograph depicting broken trochanteric nail was provided in the medical record. This complaint involves one (1) device unk - nails: tfna. This is report 1 of 1 for complaint (b)(4).

• Brand Name: UNK - NAILS: TFNA
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14161800
• MDR Text Key: 289665739
• Report Number: 2939274-2022-01398
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other

Reporter Occupation

• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: UNK - NAILS: TFNA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 04/20/2022 Patient Sequence Number: 1