MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 3.0MM DIAMOND MATCH HEAD, DISTAL BEND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8431107030D
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: a follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during an the tip of the bur was burnt during an endoscopic transnasal pituitary tumor resection the tip overheated and became burnt.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Event or Problem Description
It was reported that during an the tip of the bur was burnt during an endoscopic transnasal pituitary tumor resection the tip overheated and became burnt.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
Correction and additional information; d1, d4 & h4: catalog number provided and manufacturing/expiry dates updated.
Additional Manufacturer Narrative
D4: udi number provided.D9: device was returned and evaluated.H6: the quality investigation is complete.
Event or Problem Description
It was reported that during an the tip of the bur was burnt during an endoscopic transnasal pituitary tumor resection the tip overheated and became burnt.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

• Brand Name: 3.0MM DIAMOND MATCH HEAD, DISTAL BEND
• 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: 19694964
• Report Number: 3015967359-2024-01242
• Device Sequence Number: 12769304
• Product Code: HBE
• UDI-Device Identifier: 07613327509229
• UDI-Public: (01)07613327509229(17)241101(10)22334017
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K210377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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 Expiration Date: 11/01/2024
• Device Catalogue Number: 8431107030D
• Device Lot Number: 22334017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/21/2024; 11/22/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 07/09/2024; 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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: P/N: 8431012030D, LOT #: 23208017
• Patient Sex: Unknown