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

Model Number	703822
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
It was reported that during a surgery to address a right ankle fracture, the tip of the clamp snapped off in the patient's bone.The piece was retrieved and intra-op x-ray was used to ensure no pieces remained in the patient.Surgery was completed successfully with no delay.
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 clamp had one of its tips broken.The fracture pattern on the surface of the broken tip indicates typical brittle fracture under immense bending load.The breakage originated from the inner surface and progressed outwards.Absence of plastic deformation also confirms a brittle fracture.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 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
It was reported that during a surgery to address a right ankle fracture, the tip of the clamp snapped off in the patient's bone.The piece was retrieved and intra-op x-ray was used to ensure no pieces remained in the patient.Surgery was completed successfully with no delay.

• Brand Name: STRAIGHT REDUCTION CLAMP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 10525199
• Report Number: 0008031020-2020-02223
• Device Sequence Number: 14241699
• Product Code: LXH
• UDI-Device Identifier: 04546540703774
• UDI-Public: 04546540703774
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2020

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: L28699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1