MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT REDUCTION CLAMP VARIAX2; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	703822
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: :"broken tip of bone grasping forceps".
Additional Manufacturer Narrative
Correction - please refer to h6 component code.The reported event could be confirmed, since the device was returned for evaluation and matches the alleged issue.Device inspection revealed the following: the received clamp overall showed normal signs of usage with one of its leg broken.The fracture pattern on the surface of the broken leg indicates towards a typical brittle fracture under immense bending load.The breakage is along the notch transition point.No other deformation was observed around the breakage point, indicating towards an instantaneous breakage under a high load.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance to the values in the material specification.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on the above investigation, the root cause of the failure is user related.The breakage of one of the legs of the clamp occurred due to intra-op excessive bending load application on the leg, more than it could sustain.Ultimately leading to an instantaneous brittle fracture.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "broken tip of bone grasping forceps".The procedure could be completed successfully.The broken tip could be retrieved from the patient's body.

• Brand Name: STRAIGHT REDUCTION CLAMP VARIAX2
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 21437518
• Report Number: 0008031020-2025-00345
• Device Sequence Number: 14543018
• Product Code: LXH
• UDI-Device Identifier: 04546540703774
• UDI-Public: (01)04546540703774(10)L28727
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 703822
• Device Lot Number: L28727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2018
• 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 Age: 56 YR
• Patient Sex: Male