MAUDE Adverse Event Report: BIOMET UK LTD. OXF MP SLOT POST CUT GD MED; ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK, REUSABLE

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.The product has been returned to zimmer biomet for investigation.Patient information is not allowed by country regulations.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the instrument broke during surgery.No harm has been reported.No delay of the surgery reported.

Event Description

It was reported that the instrument broke during surgery.No harm has been reported.No delay of the surgery reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d2, d10, g4, g7, h1, h2, h3, h6, h10.The event reports the instrument fractured during surgery.No further information has been provided.The instrument was returned for evaluation.The fracture surface on the received component suggests that the fracture occurred suddenly, as opposed to fracture due to fatigue.The ultimate reason for the fracture of the oxford posterior cutting guide cannot be determined with the information available at the time of writing this report.The relevant manufacturing history records (mhrs) for the oxford posterior cutting guide have been checked and verified that the part was manufactured and sterilised in accordance with its specifications.A complaint history review for the last three years identified 2 additional similar complaints for the same item number, and 1 additional similar complaint for the same lot number.The likely condition of the device when it left zimmer biomet is conforming to specification.The likely root cause of the reported event is the instrument has surpassed its reusable life (aged).The instrument had been in the field for a maximum of 6 years and 7 months before the reported event.During this time the instrument is likely to have been subject to multiple uses and multiple decontamination and sterilisation cycles (which include chemicals and high temperatures).No corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm beyond extension to surgery time, minor, has been reported.The item was distributed conforming.The instrument has likely passed its reusable lifespan, which is well documented in the reusable instrument lifespan manual.Risk assessment: appropriate rmf and most appropriate line for the reported event.The instrument does not withstand mechanical forces which includes a severity score of 2 (exposure to anaesthesia, minor) and an occurrence rate of (b)(4) ((b)(4)).The actual severity of the reported event is s-2, and the calculated occurrence for all similar events in the last 3 years gives an occurrence score of o-2, both of which are in line with this risk file.Occurrence assessment: -the occurrence rate has been calculated using sales of associated implants and complaints for instrument for a time period of 3 calendar years before the notification date to current date.-notification date: sep 2020.-sales data time period: jan 2017 to dec 2020.-number of sales: (b)(4).-complaint data time period: 01 jan 2017 to 25 jan 2021 (current date).-number of complaints: 3.-complaint ratio: (b)(4).-severity score: 2.-this is in line with the risk file.No corrective or preventive actions are deemed necessary at this time.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: OXF MP SLOT POST CUT GD MED
• Type of Device: ORTHOPAEDIC IMPLANT AIMING/GUIDING BLOCK, REUSABLE
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10625195
• MDR Text Key: 219545106
• Report Number: 3002806535-2020-00437
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• 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: ZB140102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1