MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIOMET OXFORD UNIVERSAL FEMORAL DRILL; PROSTHESIS, KNEE

Catalog Number 32-422845

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/12/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign source- (b)(6).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation is completed, a follow-up mdr will be submitted.

Event Description

It was reported during a procedure, the drill was discovered fractured.A new one was used to complete the procedure.No adverse events have been reported as a result of the malfunction.

Event Description

It was reported during a procedure, the drill was discovered fractured.A new one was used to complete the procedure.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned items confirmed the reported event.Device history record (dhr) was reviewed and no discrepancies were found.The root cause of the fracture cannot be clearly determined, the failure of the femoral drill most lightly could be down to the loss of it cutting edges over time, with the possibility of extra force needed for the drill to cut efficiently and the lightly hood of fracturing as a result.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

Upon receipt of additional information, it was determined this report was submitted under the incorrect manufacturer registration number.Please see 3002806535-2019-00553 for all reporting on this event.

Event Description

No further event information available at the time of this report.

• Brand Name: BIOMET OXFORD UNIVERSAL FEMORAL DRILL
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8184577
• MDR Text Key: 131015158
• Report Number: 0001825034-2018-11429
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2019

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 Catalogue Number: 32-422845
• Device Lot Number: ZB120701
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/22/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 05/30/2019; 11/12/2018
• Supplement Dates FDA Received: 06/28/2019; 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1