MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP 04MM DRILL; BMET GENERAL KNEE INSTRUMENTS

Catalog Number 32-423228

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Drill bit broke in half during regular usage.

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

Drill bit broke in half during regular useage.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection confirmed the reported event.Device history record (dhr) was reviewed and no discrepancies were found.The condition of the device when it left zimmer biomet is conforming to specification.The likely cause of the reported event is wear and tear.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.

Event Description

Drill bit broke in half during regular usegae.

• Brand Name: OXF MP 04MM DRILL
• Type of Device: BMET GENERAL KNEE INSTRUMENTS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 8161029
• MDR Text Key: 130624437
• Report Number: 3002806535-2018-01273
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/24/2019

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: 32-423228
• Device Lot Number: ZB120701
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/13/2018
• Supplement Dates Manufacturer Received: 07/03/2019; 10/22/2019
• Supplement Dates FDA Received: 07/26/2019; 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1