MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AO LARGE REAMER; ARTHROSCOPE

Catalog Number	4100210000S1
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer service technician reported that the device was missing a small component while it was being serviced at the user facility.There were no adverse consequences related to this event.

• Brand Name: AO LARGE REAMER
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8687842
• Report Number: 0001811755-2019-01964
• Device Sequence Number: 3029741
• Product Code: HRX
• UDI-Device Identifier: 07613154055180
• UDI-Public: 07613154055180
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K943323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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: 4100210000S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1