MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 10MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	456.360S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that on (b)(6) 2021 there was difficulty with the set screw locking into the light screw.After multiple tries to get the light screw to lock into the light screw, the nail backed out.It was the discovered that the trochanteric fixation nail advanced (tfna) nail was broken.It was removed and replaced with another one.Concomitant device: unknown screw (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 10mm/130 deg ti cann troch fixation nail 400mm/right-ster.This is report 1 of 1 for (b)(4).
Additional 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: h3, h4, h6: sterile part 456.360s, lot 7113298: manufacturing location: monument.Manufacturing date: december 24, 2012.Expiration date: november 30, 2021.Non-sterile part: 456.360, lot 6223066: 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.
Event or Problem Description
The surgeon had difficulty with the set screw locking into the lag screw.After multiple tries of attempting to get the set screw to lock into the lag screw, the set screw would not perform this action.We then set the nail onto the back table and tried to diagnose the issue with the set screw.After analyzing the nail, it was noted there was a broken piece on the set screw.The procedure was completed with another nail with a ten (10) minute surgical delay.The patient is reportedly doing well.

• Brand Name: 10MM/130 DEG TI CANN TROCH FIXATION NAIL 400MM/RIGHT-STER
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12044437
• Report Number: 2939274-2021-03165
• Device Sequence Number: 14420649
• Product Code: HSB
• UDI-Device Identifier: 10886982227324
• UDI-Public: 10886982227324
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 456.360S
• Device Catalogue Number: 456.360S
• Device Lot Number: 7113298
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: TRAUMA; UNK - SCREWS: TRAUMA
• Patient Age: 66 YR