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

Catalog Number	CAT02504
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2023
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 tip of the device broke during the procedure.All pieces were retrieved.
Event or Problem Description
It was reported that the tip of the device broke during the procedure.All pieces were retrieved.
Additional Manufacturer Narrative
His complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: tip broken off probable root cause: design: improper raw material selection.Insufficient assembly design.Hard stop not designed correctly.Guide mouth does not stabilize guide during drilling.Manufacturing: improper assembly.Incorrect raw material used.Guide or drill not manufactured to specification.Application: use of excessive force.The reported failure mode will be monitored for future reoccurrence.*note: the investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: break-off of the phoenix drill tip in the bone (cat02504 lot 22327ag2).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: use of excessive force, interfacing issues between drill bit and guide (guide out of specification), 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: 17446341
• Report Number: 0002936485-2023-00746
• Device Sequence Number: 19511110
• Product Code: HTW
• UDI-Device Identifier: 07613252633242
• UDI-Public: 07613252633242
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Catalogue Number: CAT02504
• Device Lot Number: 22327AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown