MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE PERF L100 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Non-union Bone Fracture (2369)

Event Date 06/07/2022

Event Type  Injury  

Event Description

It was reported on (b)(6) 2022, that a revision of a tfna will be performed in 05/0p.The tfna nail was successfully removed and replaced.The reason for the exchange was a non union of the fracture side of the femoral shaft.There was no surgical delay and surgery was completed successfully.The patient status/ outcome: stable.This report is for one (1tfna helical blade perf l100 tan.This is report 2 of 4 for complaint.

Manufacturer Narrative

Additional narrative: additional product code: ktt.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.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.

• Brand Name: TFNA HELICAL BLADE PERF L100 TAN
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14884621
• MDR Text Key: 295113207
• Report Number: 2939274-2022-02451
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819660014
• UDI-Public: (01)07611819660014
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.400
• Device Lot Number: 41P7813
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 137 KG