MAUDE Adverse Event Report: SYNTHES GMBH HANDLE WITH QUICK COUPLING, SMALL; BONE TAP

Catalog Number	311.430
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
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 medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary the product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample found the to be broken from the brown hand piece.The broken fragment was returned.The complaint information has been reviewed, and it was determined that there is no allegation of deficiency related to the identity, quality, durability, reliability, safety, effectiveness or performance of the device after it was released for distribution.No further information can be reviewed, the complaint will be reassessed accordingly.A dimensional inspection was not performed due to it is not applicable to the complaint condition.A functional test was not performed due to it is not applicable to the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the handle w/quick-coupl l110 would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Dimensional inspection: n/a device history product code:311.430 lot number : 2592586 release to warehouse date :14.Apr.2010 expiration date :na supplier: (b)(4).Manufacturing site: werk selzach.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.
Event or Problem Description
It was reported that on (b)(6) 2026, the patient underwent surgery for vachp removal on the clavicle.The surgery was completed successfully with no surgical delay.Before surgery, when the distributor delivered the product in question to the hospital, it was found that the handle was chipped.The product was not used in the surgery.No further information is available.

• Brand Name: HANDLE WITH QUICK COUPLING, SMALL
• Common Device Name: BONE TAP
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): BETTLACH GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 25174054
• Report Number: 8030965-2026-04593
• Device Sequence Number: 16083067
• Product Code: HWX
• UDI-Device Identifier: 10886982187390
• UDI-Public: (01)10886982187390(10)2592586
• 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

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: 311.430
• Device Lot Number: 2592586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2010
• 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