MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE MICROFX OCD UNIVERSAL DRILL; BIT, DRILL

Catalog Number	234-200-200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2018
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 drill bit broke.All broken pieces were retrieved.
Additional Manufacturer Narrative
The product was returned for investigation and the reported failure mode was confirmed.Alleged failure: customer had microfx drill bit break going into bone.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: excessive force applied on drill, running drill in reverse, drill is started/stopped while in bone, or hard bone.The reported failure mode will be monitored for future reoccurrence.Mfg date: manufacture date is not known.
Event or Problem Description
It was reported that the drill bit broke.All broken pieces were retrieved.

• Brand Name: MICROFX OCD UNIVERSAL DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 7616938
• Report Number: 0002936485-2018-00489
• Device Sequence Number: 1946602
• Product Code: HTW
• UDI-Device Identifier: 37613327004091
• UDI-Public: 37613327004091
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2018

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: 234-200-200
• Device Lot Number: 48979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 09/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR