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

Catalog Number	3910-500-573
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke during procedure.No pieces fell into the joint space.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.Alleged failure: break.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 device manufacturer date is not known.
Event or Problem Description
It was reported that the device broke during procedure.No pieces fell into the joint space.

• 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
• MDR Report Key: 8606223
• Report Number: 0002936485-2019-00202
• Device Sequence Number: 1756674
• Product Code: HTW
• UDI-Device Identifier: 07613252598718
• UDI-Public: 07613252598718
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2019

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: 3910-500-573
• Device Lot Number: 44385
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1