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

Model Number	3910-500-573
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/29/2019
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 device broke and pieces potentially remain in the patient.
Event or Problem Description
It was reported that the device broke and pieces potentially remain in the patient.All pieces were retrieved.
Additional Manufacturer Narrative
Please note that this event was initially reported as a serious injury, but additional information now changes this event to a malfunction: it was reported that the device broke and pieces potentially remain in the patient.All pieces were retrieved.Alleged failure: in process of repair of luxation of shoulder bankart type, dr uses the rigid drill of iconix.For the customer the flexible drill cannot be used, due to the location of the injury, the doctor is difficult to drill with the rigid drill, however the dr tries to several times, finally the buck is breaked.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) excessive force applied on device, 2) starting and stopping drill, 3) pulling drill out of bone without running drill, or 4) moving drill guide during drilling.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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: 9570058
• Report Number: 0002936485-2020-00018
• Device Sequence Number: 327970
• Product Code: HTW
• UDI-Device Identifier: 07613252598718
• UDI-Public: 07613252598718
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 44387
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other