MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TFNA FENESTRATED SCREW 115MM; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.215

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

Patient Problems Non-union Bone Fracture (2369); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

Additional procode: 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 history lot: part number: 04.038.215-us, lot number: 11l8641, part manufacture date: jul 12, 2019, manufacturing location: (b)(4), part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna fenestrated screw 115mm product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.Device history review: this lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.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) 2020, the patient underwent revision surgery for proximal femur fracture due to malunion/nonunion.Tfna was removed and a smith and nephew nail was then implanted in place along with a 4.5mm proximal femur hook plate.The date of the original implant was unknown.There was no surgical delay reported.The procedure was successfully completed.This report is for one (1) tfna fenestrated screw 115mm.This is report 3 of 4 for (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 115MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10905732
• MDR Text Key: 218913824
• Report Number: 2939274-2020-05319
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982098825
• UDI-Public: (01)10886982098825
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 04.038.215
• Device Catalogue Number: 04.038.215
• Device Lot Number: 11L8641
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2020
• Patient Sequence Number: 1
• Treatment: 11MM/130 DEG TI CANN TFNA 440MM/RIGHT - STERILE; UNK - SCREWS: LOCKING; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention