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 Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2020
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
As reported: "doctor clamped down on fragment and one of the arms of the clamp snapped off.".
Event or Problem Description
As reported: "doctor clamped down on fragment and one of the arms of the clamp snapped off.".
Additional Manufacturer Narrative
The reported event that a straight reduction clamp alleged of issue ¿instrument - breakage during implantation¿ could be confirmed, since the device was returned for evaluation and matches the reported failure mode.Device inspection revealed the following: the received clamp had one of its leg broken.The fracture pattern on the surface of the broken leg 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 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, most likely during reduction of a larger bone fragment than it could sustain.Ultimately leading to an instantaneous brittle fracture.If any further information is provided, the complaint report will be updated.

• Brand Name: STRAIGHT REDUCTION CLAMP
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 10062228
• Report Number: 0008031020-2020-01493
• Device Sequence Number: 3600146
• Product Code: LXH
• UDI-Device Identifier: 04546540703774
• UDI-Public: 04546540703774
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/16/2020

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: L28777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2020
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 06/19/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 07/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1