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

Model Number 4200355042

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

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 surgical procedure, the drill bit broke.It was also reported that all broken pieces of the drill bit were successfully removed from the patient.It was further 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 reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The device was sent to product engineering who concluded that the return drill exhibited marking on the cutting surface consistent wit metal contact while in use.This contact could cause damage to the cutting surfaces and contributed to the break.It is possible that metal contact along with the application of a bending moment while in use could cause the drill to break.The instructions for use(ifu) for the handpiece/drive for use with this drill contains the following indication for use; "the radiolucent right angle drive is used to drill or ream through bone." the ifu also contains the following warning; "excessive pressure can damage either the drill bit or driver.".

Event Description

It was reported that during a surgical procedure, the drill bit broke.It was also reported that all broken pieces of the drill bit were successfully removed from the patient.It was further 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.

• 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: 9475362
• MDR Text Key: 170951228
• Report Number: 0001811755-2019-04070
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

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 Expiration Date: 07/01/2022
• Device Model Number: 4200355042
• Device Catalogue Number: 4200355042
• Device Lot Number: 19190017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 01/30/2020
• Supplement Dates FDA Received: 01/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1