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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2025
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 tip of the drill broke during the procedure.The broken piece was removed.
Event or Problem Description
It was reported that the tip of the drill broke during the procedure.The broken piece was removed.
Additional Manufacturer Narrative
Alleged failure: the doctors were utilizing the microfx drill system to microfracture a chondral defect in a hip scope.The 90deg hip length drill guide with the black snap cap were selected.The drill was chucked correctly to the corresponding laser line.The first drill hole was flawless.During the second drill, the distal end of the drill bit broke where the drill turns flexible.The drill broke while it was bottomed out in bone.The distal end of the drill bit was buried in bone with the remaining portion of the drill hanging in the joint.The drill was running at full speed before it hit bone and stayed on full speed until it snapped.Proper technique was performed from start to finish with minimal force being put on the drill, letting the drill do all of the work.To remove the piece of the drill stuck in bone, the doctor had to use a pean forcep to grab the remaining piece and mallet the handle to force the drill out of the bone.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) not running drill when removing bit from bone.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 21472338
• Report Number: 0002936485-2025-00146
• Device Sequence Number: 18330420
• Product Code: HTW
• UDI-Device Identifier: 37613327004091
• UDI-Public: 37613327004091
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 04/17/2025

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: W88257/1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 02/26/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown