MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.2MM RADIOLUCENT DRILL BIT; BIT, SURGICAL

Model Number 4200355042

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a fracture repair of distal femur with nail, two radiolucent drill bits broke at the cutting end.It was also reported that the drill fragment is completely buried in the bone and cannot be removed.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.This report is for the first drill bit that broke.

Manufacturer Narrative

H6: the quality investigation is complete.

Event Description

It was reported that during a fracture repair of distal femur with nail, two radiolucent drill bits broke at the cutting end.It was also reported that the drill fragment is completely buried in the bone and cannot be removed.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.This report is for the first drill bit that broke.

• Brand Name: 4.2MM RADIOLUCENT DRILL BIT
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10471990
• MDR Text Key: 204945575
• Report Number: 0001811755-2020-02262
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 04546540348593
• UDI-Public: 04546540348593
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 4200355042
• Device Catalogue Number: 4200355042
• Device Lot Number: 20057017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 90