MAUDE Adverse Event Report: SYNTHES GMBH TFNA FEM NAIL Ø10 R 130° L235 TIMO15; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.037.044S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
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 through a german health authority user report.The nail fractured in a case of pseudarthrosis of the former fracture (failure to heal the fracture).Patient outcome was reported as good functional outcome, pain before implant exchange, nonunion formation, no infection.Implant date: (b)(6) 2025.
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: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.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: 28-feb-2025.Expiration date: 01-feb-2035.Part number: 04.037.044s, 10mm/130 deg ti cann tfna 235mm/right ¿ sterile.Lot number: 54973p5 (sterile).Lot quantity: (b)(4).Component part(s) reviewed: part number: 21127 timoagri16.00.Lot number: 51105p2.Lot quantity: (b)(4) lb.Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated 09-jan-2025 was reviewed and determined to be conforming.Lot summary report dated 20-jan-2025 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive.Lot number: 43609p0.Lot quantity: (b)(4).One piece (1) was scrapped in cell at op #50, final inspection due to dropped part.Production order traveler met all inspection acceptance criteria apart from the one (1) piece scrapped.Part number: 04.037.942.2, lock prong, 130 degree, tfna.Lot number: 54750p2.Lot quantity: (b)(4).Six pieces (6) were scrapped in cell at op #70, final inspection due to surface finish-dings/scratches.Inspection sheet, (b)(4) rev e, met all inspection acceptance criteria.Production order traveler met all inspection acceptance criteria.Device history review: a manufacturing record evaluation was performed for the finished device with batch number 54973p5.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.
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, d10 concomitant.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.
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: corrected: h3.H3, h6: 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 revealed that tfna fem nail ø10 r 130° l235 timo15 was broken from the screw blade mating hole.A crack can be observed in the proximal fragment and several scratches on the nail surface near the fracture area.Both fragments were received.The crack condition it could have been caused by exposure to unintended forces when the implant fracture occurs and the scratches could have been caused when the implant was removed.However; with the information provided is not possible to determine a potential cause at this moment.The mode of failure of the device is multi-factorial and consideration must be given to all other potential influences such as surgical process, patient variables (e.G.Activity level and use), anatomical considerations and patient changes over time.Any conclusions from the investigational input provided have to be placed into context with all other relevant factors.A dimensional inspection for the tfna fem nail ø10 r 130° l235 timo15 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 tfna fem nail ø10 r 130° l235 timo15 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.There is no indication that a design or manufacturing issue has caused the complaint condition.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: 28-feb-2025.Expiration date: 01-feb-2035.Part number: 04.037.044s, 10mm/130 deg ti cann tfna 235mm/right ¿ sterile.Lot number: 54973p5 (sterile).Lot quantity: (b)(4).Component part(s) reviewed: part number: 21127 timoagri16.00.Lot number: 51105p2.Lot quantity: (b)(4).Inspection instruction met all inspection acceptance criteria.Certified test report supplied by (b)(4) dated 09-jan-2025 was reviewed and determined to be conforming.Lot summary report dated 20-jan-2025 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.Part number: 04.037.912.3, tfna lock drive.Lot number: 43609p0.Lot quantity: (b)(4).One piece (1) was scrapped in cell at op #50, final inspection due to dropped part.Production order traveler met all inspection acceptance criteria apart from the one (1) piece scrapped.Part number: 04.037.942.2, lock prong, 130 degree, tfna.Lot number: 54750p2.Lot quantity: (b)(4).(b)(4) were scrapped in cell at op #70, final inspection due to surface finish-dings/scratches.Inspection sheet, ns673829 rev e, met all inspection acceptance criteria.Production order traveler met all inspection acceptance criteria.Device history batch = > null.Device history review = > a manufacturing record evaluation was performed for the finished device with batch number 54973p5.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.

• Brand Name: TFNA FEM NAIL Ø10 R 130° L235 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: 24746475
• Report Number: 8030965-2026-02994
• Device Sequence Number: 21025733
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.037.044S
• Device Lot Number: 54973P5
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 04/20/2026; 05/12/2026; 05/18/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/21/2026; 05/15/2026; 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LOCKSCR F/NAILS Ø5 L 36 XL25; TFNA HELICAL BLADE PERF L110 TAN; TFNA HELICAL BLADE PERF L110 TAN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male