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

Catalog Number	3910-500-569
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2021
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 there was a potential of unintended material coming off of the device.
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.The reported failure mode will be monitored for future reoccurrence.Alleged failure: black rubber on drill came off.Probable root cause: design: -poor material selection of drill, bushing and/or guide.-poor material finish on drill and/or guide.-stackup interference or excessive wobble between drill and guide process: -drill and/or guide manufactured out of specification.-hardening or polishing processes not performed to specification.Application: -excessive force used while drilling.Manufacture date is not known.H3 other text : 81.
Event or Problem Description
It was reported that there was a potential of unintended material coming off of the device.

• Brand Name: ICONIX 2.3MM DISPOSABLE DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11398586
• Report Number: 0002936485-2021-00121
• Device Sequence Number: 14292791
• Product Code: HTW
• UDI-Device Identifier: 37613252450505
• UDI-Public: 37613252450505
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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: 3910-500-569
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1