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

Model Number	CAT02504
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2022
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 that the distal end of the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: surgeon broke 2 phoenix drill bits cat02504 in hip arthroscopy case.Doctor uses these in every case.Has for years.I was not present.He said there was absolutely no torque on guide.Very easy location to use the device.Angles were good.No guide slippage.Both broke within 3-4 drill holes.Good bone, not exceptionally hard.Patient was late fifties.Surgeon feels some sort of change in device.Size, strength, composition.Also feels like there is a waxy/plastic sleeve on the drill that did not used to be there.The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause could be use of excessive force.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the distal end of the device broke during the procedure.All pieces were retrieved.

• Brand Name: PHOENIX DRILL BIT
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15928941
• Report Number: 0002936485-2022-00722
• Device Sequence Number: 17782811
• Product Code: HTW
• UDI-Device Identifier: 07613252633242
• UDI-Public: 07613252633242
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Followup
• Report Date (Section B): 02/03/2023

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: 22203AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown