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

Model Number	CAT02504
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the tip of the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
Alleged failure: the doctor broke 6 phoenix drill bits in 1 hip arthroscopy case addressing a chondral defect on the acetabular rim.After 2-3 passes, the drill would snap at the distal end of the drill where the clear plastic sheath is, leaving the 3cm drill tip stuck in bone.We used a stryker f1 drill and system 8 drill, same result.Multiple lot #s and phoenix guides were used as well.The doctor does about 10 hip scopes a week and uses phoenix every single case for the last 6-7 years.He has noticed the past few weeks that drills are breaking much quicker.He believes there has been a change in manufacturing or materials to make these drills.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) interfacing issues between drill bit and guide (guide out of specification), 3) skiving of the drill bit on bone.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
• 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: 16382280
• Report Number: 0002936485-2023-00124
• Device Sequence Number: 20354076
• 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): 10/09/2023

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: 22287AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2022
• 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 Age: 47 YR
• Patient Sex: Male