MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI KNEE SYSTEM TIBIAL RESECTOR STYLUS ASSEMBLY; PROSTHESIS, KNEE

Model Number N/A

Device Problem Disassembly (1168)

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

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.

Event Description

During a hemi knee arthroplasty the clamp screw became loose.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.The instrument had various scratches and marking in line with the current age of the product.The screw thread had evidence of residue around the center point of the threads where most likely the loctite glue had been applied.The main body of the instrument (silver section) had evidence of some sort of adhesion material with marking on the attached gold clamp section held in by the screw.The gold clamp also had wear marks on the side of the component, however this has no bearing on the complaint issue.The rest of the instrument was functionally working, and the screw could be placed in the thread hole and tightened.However, due to the absence of the thread being set and sealed by loctite, the clamp would be tight to the body of the instrument when tightened and not loose and at a set height as intended.Device history record (dhr) was reviewed and no discrepancies were found.Review of the complaint history determined that no further action(s) is/are required.Investigation results concluded that the reported event was likely due to the screw being removed at the reprocessing and cleaning stage after use.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.

• Brand Name: OXFORD UNI KNEE SYSTEM TIBIAL RESECTOR STYLUS ASSEMBLY
• 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: 6140797
• MDR Text Key: 61308683
• Report Number: 3002806535-2016-00877
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PP010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2016
• 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: 32-422863
• Device Lot Number: ZB140302
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2014
• 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