MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø11 125° L170 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.112S
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
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.
Event or Problem Description
It was reported when installing the hip screw, the nail was already locked.The surgeon was not able to release the locked screw to remove and refit the nail.The locked screw blocked completely.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: b5.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned tfna fem nail ø11 125° l170 timo15 found that the lock prong assembly is broken.The broken fragments were returned for evaluation.No other defect was observed.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.Properly handling and attention to the approved use of the device diminishes the risk of failure.A dimensional inspection was unable to be performed due to the post-manufacturing damage.A functional test was unable to be performed due to the post-manufacturing damage.However the assembly issues are able to confirmed with the observed conditions.The overall complaint was confirmed as the observed condition of the tfna fem nail ø11 125° l170 timo15 would have contributed to the complained issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.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.Device history lot: manufacturing location: monument.Manufacturing date: 19-apr-2023.Expiration date: 01-apr-2033.Part number: 04.037.112s, 11mm/125 deg ti cann tfna 170mm-sterile.Lot number: 5587p57 (sterile).Lot quantity: (b)(4).Component part(s) reviewed: part number: 04.037.912.2 lock prong, 125 degree tfna , lot number: 5827p12, lot quantity: (b)(4), production order traveler met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive, lot number: 5454p01, lot quantity: (b)(4).Two pieces were scrapped in cell at op #50, final inspection, due to surface finish-dings/scratches.Production order traveler met all inspection acceptance criteria apart from the two pieces scrapped.Part number: 21127, timoagri16.00.Lot number: 5161p61.Lot quantity: 1,721 lbs.05-mar-2026 a manufacturing record evaluation was performed for the finished device with batch number 5587p57.No nonconformities or manufacturing irregularities have identified related to the complaint condition.Device history review: a manufacturing record evaluation was performed for the finished device with batch number 5587p57.No nonconformities or manufacturing irregularities have identified related to the complaint condition.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
Additional information received: a.What is the timing of the reported event? (pre-op, intra-op, post-op) - intra-op.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: added: d9.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TFNA FEM NAIL Ø11 125° L170 TIMO15
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• 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: 24482050
• Report Number: 8030965-2026-02058
• Device Sequence Number: 10308272
• Product Code: HSB
• UDI-Device Identifier: 10886982096302
• UDI-Public: (01)10886982096302(17)330401(10)5587P57
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup

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: 04.037.112S
• Device Lot Number: 5587P57
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 03/30/2026; 04/13/2026; 05/12/2026
• Initial Report FDA Received Date: 03/02/2026
• Supplement Report FDA Received Date: 04/01/2026; 04/14/2026; 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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 Sex: Unknown