MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.3MM TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5407FA2023
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.H3 other text : awaiting for device return to manufacturer.
Event or Problem Description
It was reported that during testing, the router was reported to be getting hot.It was also reported that this event did not occur during a surgical procedure with no patient involvement and there was no delay, no adverse consequences and no medical intervention as a result of this event.
Event or Problem Description
It was reported that during testing, the router was reported to be getting hot.It was also reported that this event did not occur during a surgical procedure with no patient involvement and there was no delay, no adverse consequences and no medical intervention as a result of this event.
Additional Manufacturer Narrative
Additional information: d4; part number provided.Correction: d9; router has not been returned by the customer.H10: lot number of device is unknown - full udi is not available.H6: the quality investigation is complete.

• Brand Name: 2.3MM TAPERED ROUTER
• 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: 18975271
• Report Number: 3015967359-2024-00554
• Device Sequence Number: 6807588
• Product Code: HBE
• UDI-Device Identifier: 07613327096729
• UDI-Public: (01)07613327096729
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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): 10/14/2024

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: 5407FA2023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 10/14/2024
• 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
• Patient Sex: Unknown