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 Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2022

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded by customer.

Event Description

It was reported that during a t2scn surgery; while drilling the proximal screw hole of nail, the drill bit broke.It was also reported that the broken piece remained in the patient.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 t2scn surgery; while drilling the proximal screw hole of nail, the drill bit broke.It was also reported that the broken piece remained in the patient.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• 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: 14593989
• MDR Text Key: 293287508
• Report Number: 3015967359-2022-01103
• 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: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• 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: 21284027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• 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