MAUDE Adverse Event Report: SYNTHES GMBH T-HANDLE CANN W/QUICK-COUPL HEX12; BONE TAP

Catalog Number	03.010.496
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent orif surgery for femoral trochanteric fractures.The surgery was completed successfully with no delay.The hospital reported that on (b)(6) 2025, there was a problem with the connection between the products in question used for the surgery.The products in question were not used clinically and did not affect the patient.No further information is available.
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, h4, h6 the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found to be problems with the locking mechanism.This can be related to the unable to assemble allegation.A functional evaluation was performed and presents difficulties for the assemble.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.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 t-handle cann w/quick-coupl hex12 would contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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 review part number: 03.010.496 lot number: 98p3049 (wo# (b)(4) manufacturing site: tuttlingen release to warehouse date: 06-may-2021.A review of the device history records was performed for the finished device lot number, and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: T-HANDLE CANN W/QUICK-COUPL HEX12
• Common Device Name: BONE TAP
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES TUTTLINGEN; unter hasslen 5; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 23363736
• Report Number: 8030965-2025-10620
• Device Sequence Number: 13292516
• Product Code: HWX
• UDI-Device Identifier: 10886982069139
• UDI-Public: (01)10886982069139(10)98P3049
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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: 03.010.496
• Device Lot Number: 98P3049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/01/2025
• Supplement Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown