MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., XL ROUND DIAMOND BUR 5.5MM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number	0485860000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor broke during the procedure.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The manufacture date is not known at this time.However, should it become available it will be provided in future reports.
Additional Manufacturer Narrative
Alleged failure: it was reported that the diamond bur broke at the base during a procedure.The failure identified in the investigation is consistent with the complaint record.The probable root causes could be excessive pressure such as bending or prying of the bur and maintained for a substantial amount of time may cause the driveshaft to finally fail due to material fatigue.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the anchor broke during the procedure.

• Brand Name: PKG., XL ROUND DIAMOND BUR 5.5MM
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• 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: benjamin ly ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18803861
• Report Number: 0002936485-2024-00177
• Device Sequence Number: 7368599
• Product Code: GFF
• UDI-Device Identifier: 37613327301541
• UDI-Public: 37613327301541
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/26/2024

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: 0485860000
• Device Lot Number: 23237CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2024
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 02/28/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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