MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.0MM CRSE DMND ROUND, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450012040DC
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility sent the device to the manufacturer for service evaluation.A fractured cutting accessory was observed in the device upon initial receipt at the manufacturer facility.No medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
D4: udi is unknown as the catalog/lot number was not reported.H6: a follow up report will be filed once the quality investigation is complete.
Additional Manufacturer Narrative
D4: part number identified d4: full udi is not available due to missing lot number.B5: added additional event details h2: device evaluated h6: the quality investigation is complete.
Event or Problem Description
The user facility sent the device to the manufacturer for service evaluation.A stuck and fractured cutting accessory was observed in the device upon initial receipt at the manufacturer facility.No medical intervention or adverse consequences were reported.

• Brand Name: 4.0MM CRSE DMND ROUND, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA
• Manufacturer Contact: kelsey barla ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 21082745
• Report Number: 3015967359-2025-00017
• Device Sequence Number: 6832347
• Product Code: HBE
• UDI-Device Identifier: 07613327096859
• UDI-Public: (01)07613327096859
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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
• Device Catalogue Number: 8450012040DC
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/16/2024
• 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: 03/14/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 04/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATALOG #5407120950A, SERIAL # (B)(6).
• Patient Sex: Unknown