MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 100MM - STERILE ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.200S

Device Problem Break (1069)

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4). Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report. 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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent for a femoral nail removal of titanium cannulated proximal femoral nailing system (tfna) due to tfna nail and fenestrated lag screw were broken. The nails were removed, and a total hip was implanted. The procedure and patient outcome are unknown. Concomitant device reported. Unknown distal locking screw (part# unknown, lot# unknown, qty unknown). Unknown end caps (part# unknown, lot# unknown, qty unknown). This complaint involves (2) devices. This report is for (1) tfna fenestrated screw 100mm, sterile. This report is 2 of 2 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 100MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12071136
• Report Number: 2939274-2021-03249
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652330
• UDI-Public: (01)07611819652330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 04.038.200S
• Device Lot Number: H537419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2021
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2018
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown
• Patient Outcome(s): Required Intervention