MAUDE Adverse Event Report: Synthes GmbH T-HANDLE/CANNULATED WITH QUICK COUPLING; Bone Tap

Catalog Number	03.010.496
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterilising department processing consignment advanced nail set - and found t handle had a slit / split in blue silicone handle.Not suitable for re-sterilising.There were no patient consequences.Upon manufacturers investigation it was noted that the instrument was chipped.
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.H11.Additional manufacturer narrative: h3, h6: part number: 03.010.496 lot number: 84808p5 product code: n/a date of manufacture: 31-oct-2025 manufacturing location: tuttlingen part expiration date: n/a nonconformance noted: n/a dhr record review: a manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.The raw material certificate was reviewed and the used material was according to the specification of the device.The photo investigation revealed that t-handle cann w/quick-coupl hex12 had crack.Visual inspection of the returned sample revealed that the blue handle of the t-handle cann w/quick-coupl hex12 was cracked.In addition, the edges of the metal cap were scratched and chipped; no fragments were received for evaluation.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 for the t-handle cann w/quick-coupl hex12 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 t-handle cann w/quick-coupl hex12 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.

• Brand Name: T-HANDLE/CANNULATED WITH QUICK COUPLING
• Common Device Name: Bone Tap
• 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 ; +1(908)386-3534
• MDR Report Key: 50817347
• Report Number: 8030965-2026-09539
• Device Sequence Number: 21370395
• Product Code: HWX
• UDI-Device Identifier: 10886982069139
• UDI-Public: (01)10886982069139(10)84808P5
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 84808P5
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown