MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE BARREL BUR 6 FLUTE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375941000
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that a small piece of the tip of a bur broke off inside a patient.It was noted that the broken piece might have been sucked out, but that is not confirmed.Looked for the piece for a while and then opened up a new bur.There are presently no adverse consequences to the patient, but hard to say for the long term now.
Additional Manufacturer Narrative
Alleged failure: a small piece of the tip of a bur broke of inside a patient.The failure(s) identified in the investigation is consistent with the complaint record.The probable causes could be the blade coming into contact with a hard object, which may have damaged the teeth and impacted the housing edges.Additionally, excessive pressure, such as bending or prying, maintained over an extended period, may cause the arthroscopic shaver blades to bend or break.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.The unit was returned without the original packaging.Therefore, the lot number (24052ce2 ) on the complaint record cannot be confirmed.However, the product description and the failure mode (or issue or problem, etc.) reported is consistent with the device returned for this event.
Event or Problem Description
It was reported that a small piece of the tip of a bur broke off inside a patient.It was noted that the broken piece might have been sucked out, but that is not confirmed.Looked for the piece for a while and then opened up a new bur.There are presently no adverse consequences to the patient, but hard to say for the long term now.

• Brand Name: BARREL BUR 6 FLUTE F-SERIES 4.0MM EACH - ORDER MULTIPLES OF 5
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 21130578
• Report Number: 0002936485-2025-00024
• Device Sequence Number: 7676583
• Product Code: GFA
• UDI-Device Identifier: 37613327054744
• UDI-Public: 37613327054744
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0375941000
• Device Lot Number: 24052CE2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown