MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PHOENIX DRILL BIT; BIT, DRILL

Model Number	CAT02504
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported the device broke during the procedure.The piece was retrieved.
Event or Problem Description
It was reported the device broke during the procedure.The piece was retrieved.
Additional Manufacturer Narrative
Alleged failure: it was reported that the drill bit was opened and attached to the chuck attachment of the system 8 cordless drill.While the surgeon was using the drill in the patient the end broke.Surgeon stopped the drill and was able to retrieve the broken end from the patient.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be excessive force applied on device.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• Brand Name: PHOENIX DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 9484448
• Report Number: 0002936485-2019-00570
• Device Sequence Number: 380072
• Product Code: HTW
• UDI-Device Identifier: 07613252633242
• UDI-Public: 07613252633242
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: CAT02504
• Device Catalogue Number: CAT02504
• Device Lot Number: 19015AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/29/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 12/17/2019
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1