MAUDE Adverse Event Report: SYNTHES GMBH TIBIAL NAIL-ADVANCED / 10MM 360MM / STERILE; NAIL, FIXATION, BONE

Catalog Number	04.043.240S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
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 report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the reaming rod may have caused the inlay to buckle up which prevented it advancing through the nail.The nail was the tried to pass over the reaming rod a few times, it didn¿t pass.They tried to straighten the poly out but were not able.Eventually the passed the nail without the reaming rod and proceeded with the case.It added about 10 minutes to the procedure.The outcome was still good.
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: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed the proximal inlay component was broken, this condition lead to the inlay to be loose and misaligned from its position within the nail.This issue can be related to the unable to assemble allegation.The mode of failure was exanimated by the jnj 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.As the device was not returned, and as-received condition could not be assessed, a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the tibial nail advanced ø10 l 360 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 manufacturing record evaluation was performed for the finished device.Product code: 04.043.240s.Lot number: 616p728.It was electronically reviewed and no nonconformances / manufacturing irregularities were identified during the manufacturing process.The product was released on: 10 feb 2022.Manufacturing site: jabil bettlach.Expiry date: 01 feb 2032.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 / 10MM 360MM / STERILE
• 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: 24754058
• Report Number: 8030965-2026-03009
• Device Sequence Number: 18433223
• Product Code: JDS
• UDI-Device Identifier: 10886982297792
• UDI-Public: (01)10886982297792(17)320201(10)616P728
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 04.043.240S
• Device Lot Number: 616P728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2022
• 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