MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP UNKNOWN_INSTRUMENTSTIRE_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number UNK_ICO

Device Problems Failure to Auto Stop (2938); No Apparent Adverse Event (3189)

Patient Problems Abrasion (1689); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

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 and got stuck in the patients bone.It was also reported that there was an unintentional dural opening and bleeding as a result of this event.No further information was provided.

Manufacturer Narrative

H6; it was clarified in this event that the perforator bit device used in this event was a non-stryker product.The device manufacturer codman has been notified.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time and got stuck in the patient's bone.It was also reported that there was an unintentional dural opening and bleeding as a result of this event.No further information was provided.Update; it was clarified in this event that the perforator bit device used in this event was a non-stryker product.The device manufacturer codman has been notified.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• 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: 14405579
• MDR Text Key: 291713719
• Report Number: 3015967359-2022-00992
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ICO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention