MAUDE Adverse Event Report: STRYKER GMBH COMBINATION REAMER ASSEMBLY OMEGA STANDARD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	704005
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2019
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
The customer reported that they set the device to a specific length and when they were using it in the case it continued to advance.They stopped drilling.There was a delay of 5 minutes while they checked if the device was properly locked.No adverse events.This device was used to complete the case.The customer could not remember which set was being used at the time (2 possible items).
Additional Manufacturer Narrative
The reported event could not be confirmed, since the returned device is conforming to specifications and fully functional.Returned device was re-assembled according to optech instructions and axial load applied.The reported event could not be reproduced.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 complaint report will be updated.
Event or Problem Description
The customer reported that they set the device to a specific length and when they were using it in the case it continued to advance.They stopped drilling.There was a delay of 5 minutes while they checked if the device was properly locked.No adverse events.This device was used to complete the case.The customer could not remember which set was being used at the time (2 possible items).

• Brand Name: COMBINATION REAMER ASSEMBLY OMEGA STANDARD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 8922846
• Report Number: 0008031020-2019-01117
• Device Sequence Number: 16203792
• Product Code: LXH
• UDI-Device Identifier: 07613327079111
• UDI-Public: 07613327079111
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• 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): 09/20/2019

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: 704005
• Device Lot Number: J11826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2019
• Initial Date Received by Manufacturer: 07/31/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 08/22/2019
• Supplement Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1