MAUDE Adverse Event Report: STRYKER GMBH COMBINATION REAMER ASSEMBLY OMEGA 3 STANDARD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	704005
Medical Device Problem Code	Mechanics Altered (2984)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2021
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.Device disposition is unknown.
Event or Problem Description
The customer reported that the triple barreled reamer which should fix in situ became lose while reaming and the wire it was reaming over became stuck and had to be removed.

• Brand Name: COMBINATION REAMER ASSEMBLY OMEGA 3 STANDARD
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• MDR Report Key: 11836388
• Report Number: 0008031020-2021-00226
• Device Sequence Number: 3193676
• Product Code: LXH
• UDI-Device Identifier: 07613327079111
• UDI-Public: 07613327079111
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/17/2021

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 Model Number: 704005
• Device Catalogue Number: 704005
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1