MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL

Model Number 4200355042

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

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 surgical procedure, it was noted that the drill bit broke.It was also reported there were no delays and no adverse consequences as a result of this event.No further information was provided.

Event Description

It was reported that during a surgical procedure, it was noted that the drill bit broke.It was also reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

Manufacturer Narrative

H6: the quality investigation is complete.H3 other text : device discarded by customer.

• Brand Name: 4.2MM RADIOLUCENT DRILL BIT
• Type of Device: BIT, SURGICAL
• 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: 13155874
• MDR Text Key: 283181330
• Report Number: 3015967359-2022-00007
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 04546540348593
• UDI-Public: 04546540348593
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

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
• Device Operator: Health Professional
• Device Model Number: 4200355042
• Device Catalogue Number: 4200355042
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 02/07/2022
• Supplement Dates FDA Received: 02/21/2022
• 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