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

Model Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problems Abrasion (1689); Stroke/CVA (1770)

Event Date 06/22/2022

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.

Event 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 there was an unintentional brain tissue damage resulting in hemiplegia and aphasia in the patient.It was further reported that post operatively the mri scan indicated the occurrence of a stroke.No further information was provided.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text : device not available for return.

Event 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 there was an unintentional brain tissue damage resulting in hemiplegia and aphasia in the patient.It was further reported that post operatively the mri scan indicated the occurrence of a stroke.No further information was provided.

• Brand Name: ZYPHR DISP CRAN PERF LRG 14/11
• Type of Device: 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; EI NA ; 214532900
• MDR Report Key: 15000369
• MDR Text Key: 295783349
• Report Number: 3015967359-2022-01292
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: 04546540716224
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5100060001
• Device Catalogue Number: 5100060001
• Device Lot Number: 22070037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention