MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM PRCSN MTCH HD, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450107530
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a surgical procedure, the device overheated.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting confirmation device is available for return.
Event or Problem Description
It was reported that during a surgical procedure, the device overheated.The procedure was completed successfully without a delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Correction: d9; h3: the device was not returned for evaluation; therefore, a root cause could not be determined for the event.H6: the quality investigation is complete.

• Brand Name: 3.0MM PRCSN MTCH HD, 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: colette chung ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 18676928
• Report Number: 3015967359-2024-00374
• Device Sequence Number: 12317943
• Product Code: HBE
• UDI-Device Identifier: 07613327097023
• UDI-Public: 07613327097023
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• 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): 06/12/2024

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: 8450107530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 02/09/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 5407120900 S/N: (B)(6); 5407120950C S/N: (B)(6)
• Patient Sex: Unknown