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

Catalog Number	234-200-200
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
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 during the procedure.The broken piece was retrieved.
Additional Manufacturer Narrative
The product was not returned for investigation and the reported failure mode was not confirmed.Alleged failure: drill bit broken.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 (technique guide instructs to run continuously during drilling) the device manufacture date is not known.The reported failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the drill bit broke during the procedure.The broken piece was 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 14676568
• Report Number: 0002936485-2022-00318
• Device Sequence Number: 5800935
• Product Code: HTW
• UDI-Device Identifier: 37613327004091
• UDI-Public: 37613327004091
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 62960-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 84 KG