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 Material Erosion (1214)

Patient Problem Insufficient Information (4580)

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a cranial procedure, the perforator bit was shedding metal debris.No further information was provided.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a cranial procedure, the perforator bit was shedding metal debris.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: 15672154
• MDR Text Key: 302698323
• Report Number: 3015967359-2022-02199
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5100060001
• Device Catalogue Number: 5100060001
• Device Lot Number: 22145027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• 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