MAUDE Adverse Event Report: STRYKER GMBH STRAIGHT REDUCTION CLAMP, BROAD VARIAX2; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number	705297
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that the tip of the repositioning forceps was broken when crimping the fracture part during operation.The broken part was removed and the surgeon confirmed that the broken piece was not left in the patient body on the image.And the operation was continued.
Event or Problem Description
It was reported that the tip of the repositioning forceps was broken when crimping the fracture part during operation.The broken part was removed and the surgeon confirmed that the broken piece was not left in the patient body on the image.And the operation was continued.
Additional Manufacturer Narrative
The reported event that straight reduction clamp, broad variax2 was alleged of 'breakage during surgery' could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by the use of excessive force.Indeed, the device inspection revealed the following: the device inspection shows that the device is overall in a good shape.Some traces of use can be noticed but no major scratches or rust traces.The tip of one of the claws of the clamp is indeed broken.The surface of the breakage shows a grey area which is not shiny, specific to high energy fracture modes.The material at the edge of the surface shows snatching areas.All of this proves that a too big sudden force was applied to the device, which lead to the breakage of the claw.As a reminder, it is clearly stated in the ifu that: "[¿].Always treat the instrument carefully to avoid surface damage or alterations to the instrument geometry.The design of the instrument must not be modified in any way.[¿]".A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.

• Brand Name: STRAIGHT REDUCTION CLAMP, BROAD VARIAX2
• Common Device Name: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8122218
• Report Number: 0008031020-2018-01017
• Device Sequence Number: 1569123
• Product Code: HXD
• UDI-Device Identifier: 07613327125252
• UDI-Public: 07613327125252
• Combination Product (Y/N): N
• 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): 02/08/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/01/2018
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 48 YR