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

Catalog Number 3910-500-569

Device Problems Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2021

Event Type  malfunction  

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 Description

It was reported that there was a potential of unintended material coming off of the device.

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 Description

It was reported that there was a potential of unintended material coming off of the device.

• Brand Name: ICONIX 2.3MM DISPOSABLE DRILL
• Type of Device: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11398586
• MDR Text Key: 239094074
• Report Number: 0002936485-2021-00121
• Device Sequence Number: 1
• Product Code: HTW
• UDI-Device Identifier: 37613252450505
• UDI-Public: 37613252450505
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 3910-500-569
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/03/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 02/03/2021
• Supplement Dates FDA Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1