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	05/24/2018
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 product broke during use.All broken pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: microfracture was being carried out in a knee arthroscopy procedure using the microfx instrumentation.The microfx ocd drill bit broke at the distal end into to 2 pieces, leaving other small bits of metal debris within the joint.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 product was returned for investigation and the failure mode will be monitored for future reoccurrence.The device manufacturer date is not known.
Event or Problem Description
It was reported that the product broke during use.All broken pieces were retrieved and the procedure was completed successfully.

• 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: 7627612
• Report Number: 0002936485-2018-00498
• Device Sequence Number: 1819018
• Product Code: HTW
• UDI-Device Identifier: 37613327004091
• UDI-Public: 37613327004091
• Combination Product (Y/N): N
• Initial Reporter State: VI
• Initial Reporter Country: AU
• 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): 07/30/2019

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: 234-200-200
• Device Lot Number: LOT 64776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1