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

Model Number	703822
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the instrument broke the tip during surgery, the fragment was removed and discarded at the hospital.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows signs of continuous usage.The clamp had one of its tip broken.The breakage pattern on the surface of the broken tip indicates typical brittle breakage under high bending load.The breakage originated from the inner surface and progressed outwards.Absence of plastic deformation also confirms a brittle breakage.Furthermore, a hardness test according to rockwell on the returned item indicates the material being in accordance with 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 investigation, the root cause was attributed to user related issue.The failure was caused by excessive bending load application intraoperatively leading to an instantaneous brittle fracture.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "the instrument broke the tip during surgery, the fragment was removed and discarded at the hospital.".

• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16715460
• Report Number: 0008031020-2023-00132
• Device Sequence Number: 7263730
• Product Code: LXH
• UDI-Device Identifier: 04546540703774
• UDI-Public: 04546540703774
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 07/28/2023

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 Model Number: 703822
• Device Catalogue Number: 703822
• Device Lot Number: L28838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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: Male