MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE ICONIX 1.4MM DISPOSABLE DRILL; BIT, DRILL

Catalog Number	3910-500-568
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the drill broke off and remained in the patient.
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.
Additional Manufacturer Narrative
The device manufacturer date is not known.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 bit broken and remained inside the patient.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 (iconix without needles disposable drill only).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.
Event or Problem Description
It was reported that the tip of the drill broke off and remained in the patient.

• Brand Name: ICONIX 1.4MM DISPOSABLE 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: 15322748
• Report Number: 0002936485-2022-00495
• Device Sequence Number: 14775580
• Product Code: HTW
• UDI-Device Identifier: 37613252450499
• UDI-Public: 37613252450499
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-500-568
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female