MAUDE Adverse Event Report: SYNTHES GMBH 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 255MM-STERILE; NAIL, FIXATION, BONE

Catalog Number	04.034.431S
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the implant box was labelled according to the intended specification, and the sterile packaging was intact and properly sealed.However, upon opening, the contents did not match the product label, resulting in an incorrect implant being supplied.This forced the surgeon to use a longer nail than intended.No surgical delay.Procedure was completed successfully.
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: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The employee scans the processing end time in the clean room.In order to close the production order and release it for the next process step (release is done in the erp), the employee needed to go to another table and scan the batch record.Here the batch record is separated from the products.In order to close the clean room process step, the employee had to take the batch record away from the products, bring it to another scanning work station.She might have taken 2 batch records at the same time to this scanning work station and upon return might have mixed up / wrongly allocated the two batch records to the products.This implies subsequent mistakes in label verification during final packaging.The supplier site accepts this complaint as manufacturing related.A functional test was not performed since it was not applicable to the complaint condition.A dimensional inspection was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the expert tn ø10 w/prox-bend cann l255 tan would have contributed to the complained device issue.Based on the information currently available, a product issue was identified during the investigation of the sample received.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history lot part:04.034.431s lot:282l802 manufacturing site: werk selzach supplier: (b)(4) release to warehouse date: 06 mar 2024 expiration date: 01 mar 2034.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 04.034.431 synthes lot:h109395 supplier lot:h109395 release to warehouse date: may 20, 2016 manufactured by: synthes monument.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this 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: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 255MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• 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: 22912613
• Report Number: 8030965-2025-08837
• Device Sequence Number: 9055303
• Product Code: JDS
• UDI-Device Identifier: 10886982095183
• UDI-Public: (01)10886982095183(17)340301(10)282L802
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K040762
• 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: 04.034.431S
• Device Lot Number: 282L802
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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