MAUDE Adverse Event Report: STRYKER GMBH VARIAX2 STRAIGHT REDUCTION CLAMP, BROAD

Catalog Number	705297
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "one tip of the reduction forceps has broken off.".

• Brand Name: VARIAX2 STRAIGHT REDUCTION CLAMP, BROAD
• Common Device Name: CLAMP
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24559244
• Report Number: 0008031020-2026-00416
• Device Sequence Number: 8828873
• Product Code: HXD
• UDI-Device Identifier: 07613327125252
• UDI-Public: (01)07613327125252(10)L28818
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2026

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: 705297
• Device Lot Number: L28818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown