MAUDE Adverse Event Report: BIOMET UK LTD. OXFORD UNI PH3 TIBIAL IMPACTOR; PROSTHESIS, KNEE

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Expiration date - na.Date implanted - na.Date explanted - na.Manufacture date ¿ ni.

Event Description

During a partial knee arthroplasty the screw of the tibial impactor fractured during impaction.

Manufacturer Narrative

(b)(4).Reported event was confirmed by visual inspection of the returned device.Device history record (dhr) was reviewed and no discrepancies were found.Cause of the reported event was most likely due to customer error whilst using the device in situ.It can be concluded that the instrument returned in this evaluation was conforming to pre-defined drawing specification.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 PH3 TIBIAL IMPACTOR
• Type of Device: PROSTHESIS, KNEE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 6261738
• MDR Text Key: 65208006
• Report Number: 3002806535-2017-00033
• Device Sequence Number: 1
• Product Code: NRA
• Combination Product (y/n): N
• PMA/PMN Number: PN/A
• 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: 02/14/2018

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: N/A
• Device Catalogue Number: 32-420932
• Device Lot Number: ZB141001
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2017
• Initial Date Manufacturer Received: 12/19/2016
• Initial Date FDA Received: 01/18/2017
• Supplement Dates Manufacturer Received: 08/18/2017; 01/24/2018
• Supplement Dates FDA Received: 09/15/2017; 02/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1