MAUDE Adverse Event Report: SYNTHES GMBH Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number	530.791
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during inspection in the cleanroom, the q-coupling for kwires and pinsdiameter1.5-4.0mm device fell apart.According to the reporter, the technician was gently encouraging water out of the device when it fell apart.This event did not occur during surgery.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Device was used for treatment, not diagnosis.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated, and no conclusion can be drawn at this time.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Device was used for treatment, not diagnosis.H11 additional narrative: the actual device was returned for evaluation.A visual and functional assessment was performed on the device.It was determined that the device failed the following pretest steps: general condition, check function of adjusting sleeve, check function of lever, check cannulation of attachment, and check tool quick coupling.The device was evaluated and the following failures were identified: internal finding : worn gear, functional : fell apart - unattached, visual : component damaged, and functional : will not hold k-wire.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to component failure from wear.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.Device was used for treatment, not diagnosis.H11 additional narrative: the device was functionally / visually tested according to the service manual.The described failure by the customer was confirmed.The device was visually inspected as received from the customer.It was found that the device failed visual inspection.Based on service record and provided photo: the device failed the following inspection criteria according to the pre-repair: 10 general condition: fail 30 check function of adjusting sleeve: fail 40 check function of lever: fail 50 check cannulation of attachment: fail 80 check tool quick coupling: fail during the assessment of the device and the provided photo, it was found that the device fell apart and due to this most of the test steps could not be performed.The most probable cause for the found defect, is normal wear over time.This is supported by the fact that the device was never returned for service since the manufacturing in september 2017.As part of synthes quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use states the following regarding the reported issue that was observed by the user: servicing this system requires regular maintenance service, at least once a year, in order to maintain its functionality.This service has to be performed by the original manufacturer or an authorized site.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• Brand Name: Q-COUPLING FOR KWIRES AND PINSDIAMETER1.5-4.0MM
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 23063258
• Report Number: 8030965-2025-09382
• Device Sequence Number: 10044616
• Product Code: GEY
• UDI-Device Identifier: 07611819491861
• UDI-Public: (01)07611819491861
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 530.791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2025
• Supplement Date Received by Manufacturer: 10/13/2025; 11/05/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/15/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2017
• 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