MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD PH3 TIB GROOVE CUTTER; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported that the handles on the instrument is cracked and can no longer be used in procedures.No further information is available at this time.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Visual inspection of the returned items identified there is a crack in the handle, therefore the reported event is confirmed.Device history record (dhr) was reviewed and no discrepancies were found.The likely condition of the device when it left zimmer biomet is conforming to specification.The reported event is likely to be cause by repeated cleaning and sterilisation cycles.Action resulted in a material change to the handle from radel to stainless steel.The stainless steel handle is more robust and able to withstand the cleaning/sterilisations cycles required for it to perform to its intended function.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

It was reported that the handles on the instrument is cracked and can no longer be used in procedures.No further information is available at this time.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

• Brand Name: OXFORD PH3 TIB GROOVE CUTTER
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer (Section G): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7048668
• MDR Text Key: 93432747
• Report Number: 3002806535-2017-01069
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 32-400691
• Device Lot Number: ZB100601
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/21/2017
• Supplement Dates Manufacturer Received: 04/06/2018; 11/15/2019
• Supplement Dates FDA Received: 04/06/2018; 11/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1