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

Model Number	4100231000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device was missing components during testing prior to a procedure.  there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: REAMER
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11787061
• Report Number: 3015967359-2021-00802
• Device Sequence Number: 3937946
• Product Code: HRX
• UDI-Device Identifier: 04546540068224
• UDI-Public: 04546540068224
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/06/2021

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: 4100231000
• Device Catalogue Number: 4100231000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1