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

Catalog Number	3910-500-571
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of an iconix drill broke off during drilling.The broken fragment remained temporarily in the joint, but was immediately removed and left no residue in the patient's body.The device was used for the first time after purchase.
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
It was confirmed that the device was discarded and will not be returned.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 broken.Probable root cause: 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 an iconix drill broke off during drilling.The broken fragment remained temporarily in the joint, but was immediately removed and left no residue in the patient's body.The device was used for the first time after purchase.

• Brand Name: ICONIX 1.4MM 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: andy dobos ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 22146508
• Report Number: 0002936485-2025-00510
• Device Sequence Number: 18052116
• Product Code: HTW
• UDI-Device Identifier: 07613252506720
• UDI-Public: 07613252506720
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: 3910-500-571
• Device Lot Number: 75198
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2025
• Supplement Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male