MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO TRINKLE DRILL; ARTHROSCOPE

Model Number	4100160000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer service technician reported that the device had a component missing while it was being serviced at the user facility.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
It was determined after receiving further clarification from receipt of the device that this event was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify a mdr was not required for this event.The piece of the device that was originally described as being separate from the device was verified to be the colored id ring.The id ring has been determined by the manufacturer that it would not share the same potential risk and harm as another smaller or unknown component as originally described.
Event or Problem Description
The manufacturer service technician reported that the device had a component missing while it was being serviced at the user facility.There were no adverse consequences related to this event.

• Brand Name: TRINKLE DRILL
• Common Device Name: ARTHROSCOPE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9475347
• Report Number: 0001811755-2019-04066
• Device Sequence Number: 2258945
• Product Code: HRX
• UDI-Device Identifier: 04546540068200
• UDI-Public: 04546540068200
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 06/16/2020

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: 4100160000
• Device Catalogue Number: 4100160000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/22/2019
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 06/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1