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

Catalog Number	703822
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
Event or Problem Description
Both point to point forceps on the variax 2 foot and ankle tray broke.The broken pieces were removed and an x-ray confirmed they were no longer present in the patient.The surgeon was aware and continued the case using a hospital alternative.Procedure was completed successfully with no adverse consequences or surgical delay reported.
Additional Manufacturer Narrative
The reported event could be confirmed.The device inspection revealed the following: visual inspection: confirms a broken forcep tip on reduction clamp.Additional inspection reveals a rough surface on breakage surface indicating an instant fracture.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.Based on investigation, the root cause was attributed to a user related issue.The failure was caused by exposure of forcep tip to excessive force due to mishandling of the instrument.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Both point to point forceps on the variax 2 foot and ankle tray broke.The broken pieces were removed and an x-ray confirmed they were no longer present in the patient.The surgeon was aware and continued the case using a hospital alternative.Procedure was completed successfully with no adverse consequences or surgical delay reported.

• 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: 9216228
• Report Number: 0008031020-2019-01489
• Device Sequence Number: 11193776
• Product Code: LXH
• UDI-Device Identifier: 04546540703774
• UDI-Public: 04546540703774
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 01/06/2020

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 Catalogue Number: 703822
• Device Lot Number: L28752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 10/21/2019
• Supplement Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR