MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP DRILL BIT 2.8MM (7/64'') X 128.0MM; BIT, SURGICAL

Model Number 0277082085S2

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device not returned.

Event Description

It was reported that during a total hip arthroplasty procedure, the drill bit broke right before the threaded end.It was also reported that the surgeon determined it was safer to leave the drill bit fragment in the bone and there were no delays and no adverse consequences as a result of this event.It was further reported that the drill bit was reprocessed and the procedure was completed successfully.

Event Description

It was reported that during a total hip arthroplasty procedure, the drill bit broke right before the threaded end.It was also reported that the surgeon determined it was safer to leave the drill bit fragment in the bone and there were no delays and no adverse consequences as a result of this event.It was further reported that the drill bit was reprocessed and the procedure was completed successfully.

Manufacturer Narrative

H6: the quality investigation is complete.

• Brand Name: DRILL BIT 2.8MM (7/64'') X 128.0MM
• Type of Device: BIT, SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11724819
• MDR Text Key: 249722300
• Report Number: 3015967359-2021-00518
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 07613153088981
• UDI-Public: 07613153088981
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

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: 0277082085S2
• Device Catalogue Number: 0277082085S2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/26/2021
• Supplement Dates Manufacturer Received: 06/01/2021
• Supplement Dates FDA Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1