MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DHS REAMER ATTACHMENT

Catalog Number	4100215000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The device had small components missing during a service evaluation at the manufacturer facility.  there were no adverse consequences related to this event.

• Brand Name: DHS REAMER ATTACHMENT
• Common Device Name: DHS REAMER ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8400619
• Report Number: 0001811755-2019-00775
• Device Sequence Number: 10860318
• Product Code: HWE
• UDI-Device Identifier: 07613327116397
• UDI-Public: 07613327116397
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 03/07/2019

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: Other
• Device Catalogue Number: 4100215000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1