MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD MED; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign: event occurred in (b)(6).Concomitant medical products: the product has been requested to be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that upon removal of the oxford posterior femoral cutting guide, one of the two pegs broke off and remained in the bone of the patient.To remove the broken off peg out of the patient¿s bone an additional 2mm drill hole was needed.

Event Description

It was reported that upon removal of the oxford posterior femoral cutting guide, one of the two pegs broke off and remained in the bone of the patient.To remove the broken off peg out of the patient¿s bone an additional 2mm drill hole was needed.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to r &d for evaluation.Upon removal of the oxford posterior femoral cutting guide, of the two peg broke off and remained in the bone of the patient.To remove the broken off peg out of the patient¿s bone an additional 2mm drill hole was needed.The instrument shows light scratches throughout, as well as some deeper scratches/gouges, which are indicative of its repeated use.The large pin had detached from the instrument¿s main body.The surface of the pin around the welded region shows deep scratches and polishing of the fracture surfaces of the main body of the instrument and of the large pin.Both surfaces appear slightly burnished.Signs of corrosion and/or biological deposits, in the form of brown discoloration and pitting, are visible on the surface around the welded area on the main body side of the instrument, however the fracture surface itself shows no signs of corrosion.Both fracture surfaces appear irregular and featureless, thus suggesting a sudden overload fracture via a brittle mechanism.An oxford posterior cutting guide was returned due to fracture during surgery, after a maximum period of approximately 7 years and 3 months in use.The fracture surface on the received component suggests a sudden overload fracture via a brittle mechanism of fracture.Based on the information provided, it appears that the reported instrument failure can be ascribed to general wear due to its repeated use and reprocessing.Other contributing factors, for example correct usage according to the surgical technique, cannot be discussed with the available information.The reprocessing instructions for reusable surgical instruments provide the following relevant statement: limitations on reprocessing: end of life is normally determined by wear and damage due to use.A review of the complaints database shows that we have received 2 reported events for peg fracture for the same item number 32-422981 prior to the reported event.The severity of the reported event for similar complaints are in line with the risk file.The overall score is moderate risk.Capa: no corrective or preventive action required at this time.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.

• Brand Name: OXF MP SLOT POST CUT GD MED
• 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: 11997676
• MDR Text Key: 256180519
• Report Number: 3002806535-2021-00258
• Device Sequence Number: 1
• Product Code: HXC
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• 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: 32-422981
• Device Lot Number: ZB140101
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1