MAUDE Adverse Event Report: SYNTHES GMBH 10MM/125 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.012S
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #(b)(4) this report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample showed damage at the lateral blade hole of the 10/125 deg ti cann tfna 170 - sterile.No allegation is associated with this product; the damage was caused by another instrument during reaming.A dimensional inspection was not performed due to post manufacturing damage.A functional test was not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the 10/125 deg ti cann tfna 170 - sterile would contribute to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a device history manufacturing location: monument manufacturing date: 04-dec-2023 expiration date: 31-oct-2033 part number: 04.037.012s, 10mm/125 deg ti cann tfna 1700mm ¿ sterile lot number: 8681p92 (sterile) lot quantity: 12 a manufacturing record evaluation was performed for the finished device with batch number 8681p92.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Component part(s) reviewed: part number: 04.037.912.2, lock prong 125 degree, tfna lot number: 8686p06 lot quantity: 96 production order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive lot number: 8150p90 lot quantity: 400 production order travelers met all inspection acceptance criteria.Part number: 21127, timoagri16.00 lot number: 8433p88 lot quantity: 1,986 lbs.Inspection instruction met all inspection acceptance criteria.
Event or Problem Description
It was reported that on (b)(6), 2026, connecting screw for 125° tfna aiming arm cracked while inserting a nail.This caused the guide to become loose, subsequently causing the guide wire to miss the nail.When reaming for a lag screw, the nail was damaged due to the miss placed guide wire.The nail had to be removed and replaced with a new one to finish the procedure.There was 30 minutes surgical delay.Procedure was successfully completed.Patient outcome was unknown.

• Brand Name: 10MM/125 DEG TI CANN TFNA 170MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25276079
• Report Number: 8030965-2026-04840
• Device Sequence Number: 21121368
• Product Code: HSB
• UDI-Device Identifier: 10886982095701
• UDI-Public: (01)10886982095701(17)331031(10)8681P92
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 04.037.012S
• Device Lot Number: 8681P92
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/21/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female