MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 2.3MM REUSABLE DRILL; BIT, DRILL

Model Number	3910-500-573
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the device broke during the procedure.The tip was retrieved during the same procedure.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that the device broke during the procedure.The tip was retrieved during the same procedure.
Event or Problem Description
It was reported that the device broke during the procedure.The tip was retrieved during the same procedure.
Additional Manufacturer Narrative
This 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: drill tip broken probable root cause: design drill design too weak drill material too weak manufacturing processes selected weaken drill material drill extends too far beyond guide bushing does not keep drill in orientation with guide process drill manufactured out of specification application excessive force while drilling.Selection of wrong drill.Reuse of disposable drill.Use of reusable drill past lifetime (after it has become dull) starting and stopping drill.Pulling drill out of bone without running drill.Moving drill guide during drilling.The reported failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• Brand Name: ICONIX 2.3MM REUSABLE DRILL
• 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 13192572
• Report Number: 0002936485-2022-00019
• Device Sequence Number: 5199363
• Product Code: HTW
• UDI-Device Identifier: 07613252598718
• UDI-Public: 07613252598718
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/08/2022

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: 3910-500-573
• Device Catalogue Number: 3910-500-573
• Device Lot Number: NR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown