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

Catalog Number	234-200-200
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/17/2019
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 the tip broke during the procedure.The pieces were retrieved.
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: tip break.Probable root cause: design: -drill too dull or dulls quickly, inefficient flute design, requires excessive force to advance.-drill not in alignment with guide.-drill allowed to extend too far out of guide.Process: -drill manufactured out of specification; -drill guide manufactured out of specification.Application: -excessive axial force on drill; -run drill in reverse; -reuse/resterilization of single-use device, or use of a single drill on multiple defects; -guide is translated and/or rotated during drilling; drill not in alignment with guide; -user does not use snap cap, drills too deep; -drill is started/stopped while in bone.The device manufacture date is not known.
Event or Problem Description
It was reported the tip broke during the procedure.The 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: 9310305
• Report Number: 0002936485-2019-00504
• Device Sequence Number: 16615274
• Product Code: HTW
• UDI-Device Identifier: 37613327004091
• UDI-Public: 37613327004091
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2020

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: 140461
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 90