MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10/130 DEG TI CANN TFNA 360/RIGHT - SILE; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.037.056S

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that on (b)(6) 2021, the surgeon removed a broken tfna from a patient.The original implantation date is unknown.It is unknown if there was a surgical delay.The procedure was successfully completed.Patient outcome was successful.Concomitant devices reported: unknown nail head elements: tfna helical blade (part# unknown, lot# unknown, quantity# 1); unknown screws: locking (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) 10mm/130 deg ti cann tfna 360mm/right - sterile.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: product complaint (b)(4).Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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: manufacturing location: monument.Manufacturing date: 31-jan-2020, expiration date: 31-dec-2029, part number: 04.037.056s, 10mm/130 deg ti cann tfna 360mm/right ¿ sterile, lot number: 39p4527 (sterile).This lot met all dimensional, visual, sterilization and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 04.037.912.3, tfna lock drive.Lot number: 13l2671.Part number: 04.037.912.4, wave spring, shim ended.Lot number: 11l3010.Part number: 04.037.942.2, lock prong 130 degree, tfna.Lot number: 5l45951.Part number: 21127, timoagri16.00.Lot number: 23p3913.Device history batch: null.Device history review: 24-feb-2021: dhr reviewed by: mschoenfeld this lot met all dimensional, visual, sterility 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.

• Brand Name: 10/130 DEG TI CANN TFNA 360/RIGHT - SILE
• 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: 11495085
• MDR Text Key: 246494920
• Report Number: 2939274-2021-01320
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982096128
• UDI-Public: 10886982096128
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.037.056S
• Device Catalogue Number: 04.037.056S
• Device Lot Number: 39P4527
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2021
• Patient Sequence Number: 1
• Treatment: UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE; UNK - SCREWS: LOCKING
• Patient Outcome(s): Required Intervention