MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL ADVANCED Ø10 L 315; NAIL, FIXATION, BONE

Catalog Number	04.043.225S
Medical Device Problem Codes	Break (1069); Crack (1135); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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.Additional narrative: 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) 2025, the patient underwent surgery with tna for tibial shaft fractures.The surgeon used a reaming rod by slightly bending it, then performed reaming, and inserted the nail.Following the nail insertion, the surgeon removed the nail to reinsert the blocker pin, but the nail became stuck with the reaming rod.The nail was removed successfully by backsliding, but the distal inlay of the nail cracked and broke.The surgeon reinserted another nail with a different length.The surgery was completed successfully with 30 minutes of delay.
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.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.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.
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: h3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found the proximal inlay component was broken, the nail implant surface shows evidence from surgical manipulation.Mating device rod was not returned for evaluation, however, due to the condition of the inlay, the reported condition can be confirmed.Broken fragment was not returned for evaluation.The mode of failure was exanimated by the depuy synthes r&d team and established the potential cause is traced to design of the inlay.It was found that the reaming rod will contact the inlays either due to the bend in the nail or a bend put in the reaming rod by the surgeon or both.By design there is a clip feature that snaps the inlay in place into the nail when assembled.At times it was shown that the contact made by the reaming rod is exerting enough force on the inlay to overcome the retention of that clip, either leading to the inlay being dislodged or damaged.A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the tibial nail advanced ø10 l 315 would have contributed to the complained device issue.Based on the investigation findings, the root cause is traced to design.The product issue has been addressed through depuy synthes quality system.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot a dhr evaluation was performed for the finished device product code: 04.043.225s lot number: 51000p8 it was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 14-february-2025 manufacturing site: jabil bettlach.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TIBIAL NAIL ADVANCED Ø10 L 315
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23864448
• Report Number: 8030965-2025-12837
• Device Sequence Number: 13263602
• Product Code: JDS
• UDI-Device Identifier: 10886982297761
• UDI-Public: (01)10886982297761(17)350201(10)51000P8
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201336
• 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: Other Health Care Professional
• Type of Report: Initial,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: 04.043.225S
• Device Lot Number: 51000P8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/06/2026; 01/22/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/07/2026; 01/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• 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: UNK - REAMING RODS
• Patient Age: 67 YR
• Patient Sex: Female