MAUDE Adverse Event Report: Synthes GmbH Collinear Reduction Clamp Sliding Mechan; Forceps

Catalog Number	314.291
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2026, during the procedure, a curved plate was used, which was molded to the anatomy of the patient.Subsequently, the reduction was initiated using the different clamps available in the system.During this process, the specialist asked for the colineal clamp, however, this did not allow the reduction completely, so i showed the specialist the longest arm available for the clamp.Once the long arm is mounted, we begin to make the reduction.At a certain moment, while the specialist was activating the clamp, it broke.Immediately, the clamp was released and the procedure continued using the other reduction options available in the system.Images showed the fragment was removed.No surgical delay.No patient harm.
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.

• Brand Name: Collinear Reduction Clamp Sliding Mechan
• Common Device Name: Forceps
• Manufacturer (Section D): Synthes GmbH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; +1(908)386-3534
• MDR Report Key: 50816970
• Report Number: 8030965-2026-09535
• Device Sequence Number: 16114284
• Product Code: HTD
• UDI-Device Identifier: 07611819280595
• UDI-Public: (01)07611819280595(10)190279-101
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• 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: 314.291
• Device Lot Number: 190279-101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2020
• 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