MAUDE Adverse Event Report: STRYKER GMBH REPOSITIONING FORCEPS L143MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	702932
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Disposed by hospital.
Event or Problem Description
It was reported that, during a primary procedure on a right clavicle, that the repositioning forceps broke while in use.Another device was available for use in the o.R.Surgery was completed successfully with no delay.No adverse consequences reported.

• Brand Name: REPOSITIONING FORCEPS L143MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8784558
• Report Number: 0008031020-2019-00824
• Device Sequence Number: 2665732
• Product Code: LXH
• UDI-Device Identifier: 04546540414182
• UDI-Public: 04546540414182
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 07/12/2019

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: 702932
• Device Lot Number: XFAX09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR