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

Model Number	3910-500-573
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
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 tip of the drill broke during the procedure and remained in the guide.Please note, per (b)(4), this reusable drill is only compatible with the iconix straight guides.
Event or Problem Description
It was reported that the tip of the drill broke during the procedure and remained in the guide.Please note, per ifu p19311, this reusable drill is only compatible with the iconix straight guides.
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: tip snapped off.Probable root cause: design.Drill incompatible with guide.Drill material not flexible enough to accommodate curved guides.Bushing difficult to insert through guide.Process: drill guide allows for drill to become stuck during insertion/removal.Drill and/or guide not manufactured to specifications.Application: use of wrong drill with guide.Drill not inserted straight down into guide.Excessive force during drilling deforms drill guide, allowing drill to stick during removal.The reported failure mode will be monitored for future reoccurrence.

• 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: 13714790
• Report Number: 0002936485-2022-00116
• Device Sequence Number: 4314122
• Product Code: HTW
• UDI-Device Identifier: 07613252598718
• UDI-Public: 07613252598718
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022

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: 31749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 02/08/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/20/2022
• 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