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

Catalog Number	703822
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
Event or Problem Description
During reduction of clavicle using straight reduction clamp, the tip of the clamp was broken off.The broken piece of the clamp fell outside the patient.The surgery was completed with another clamp.
Event or Problem Description
During reduction of clavicle using straight reduction clamp, the tip of the clamp was broken off.The broken piece of the clamp fell outside the patient.The surgery was completed with another clamp.
Additional Manufacturer Narrative
The reported event that straight reduction clamp, broad variax2 was alleged of 'breakage during surgery' could be confirmed.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.However, based on complaint history review, the root cause could most probably be attributed to the misuse of the product by the user.Nevertheless, it is important to receive the product in order to subject it to adequate testing.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 the device is returned or if any additional information is provided, the investigation will be reassessed.

• 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: 8025156
• Report Number: 0008031020-2018-00912
• Device Sequence Number: 13780979
• Product Code: LXH
• UDI-Device Identifier: 04546540703774
• UDI-Public: 04546540703774
• 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): 12/20/2018

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: L28816
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 11/22/2018
• Initial Report FDA Received Date: 10/31/2018
• Supplement Report FDA Received Date: 12/20/2018
• 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: 60 YR