MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP ZYPHR DISP CRAN PERF LRG 14/11; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5100060001
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that the patient received a left temporal cortical wound as a result of this event.On the night following the incident, the patient presented with 2 epileptic seizures requiring the initiation of medication which cannot be attributed with certainty to the incident as the patient has other cortical lesions linked to a meningioma.The procedure was completed successfully without a clinically significant delay.This report is for the second device that failed to disengage.
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 a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that the patient received a left temporal cortical wound as a result of this event.On the night following the incident, the patient presented with 2 epileptic seizures requiring the initiation of medication which cannot be attributed with certainty to the incident as the patient has other cortical lesions linked to a meningioma.The procedure was completed successfully without a clinically significant delay.This report is for the second device that failed to disengage.
Additional Manufacturer Narrative
H2: correction - changed to adverse event only, no device problem found.H2: device was evaluated.H6: the quality investigation is complete.

• Brand Name: ZYPHR DISP CRAN PERF LRG 14/11
• 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: 20515304
• Report Number: 3015967359-2024-02238
• Device Sequence Number: 8616790
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: (01)04546540716224(17)270301(10)24075017
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2024

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: 5100060001
• Device Lot Number: 24075017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/12/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown