MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI PH3 SPH CUTTER SML ALL; KNEE ARTHROPLASTY

Model Number N/A

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not 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.Product has not been returned.

Event Description

It was reported tat the doctor has reported that the reamer (spherical cutter) is not performing as required, and has requested a replacement.No delay reported.No harm of the patient or the user reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the device history records did not identify any discrepancies that would have contributed to the reported event.A review of the complaint database over the last 3 years has found 3 similar complaints identified with this item number including (b)(4), and 1 similar complaint identified for this lot number including (b)(4).Should the complaint product become available, the complaint investigation will be updated as appropriate.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.The root cause of the issue could not be determined with the information currently available, therefore the specific failure cause within the risk tables could not be selected for comparison.The details of the reported event do not allege that there was any patient harm or delay to surgery.The reported event states reamer not functioning properly.This incident has a severity of 1 (negligible) defined within the severity table as: no / virtually no injury to the patient or user.No impact to patient management.Insignificant or no device impairment or impact to patient (implants).Product system functionality not affected.The outcome of the reported event is considered to be within the severity of the rmf.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.

Event Description

It was reported tat the doctor has reported that the reamer (spherical cutter) is not performing as required, and has requested a replacement.Excess force had to be applied for the reamer to cut.No delay reported.No harm of the patient or the user reported.

Manufacturer Narrative

(b)(4).This follow-up final report is being submitted to relay additional information.Complaint summary: a visual check of the returned product (oxford uni spherical cutter small item (b)(4), lot.Zb151001) confirms that the cutting edges are worn on both the inner and outer parts of the cutter, the cutter otherwise appears to be in good condition.A dimensional inspection is not required for this event as this reported event is for a worn cutter.The root cause of the cutter not performing as expected, is that the product has exceeded its useful life as there is evidence of wear on all the cutting edges.This suggests the instrument has been used for many procedures since it was manufactured in 2015.The batch part is conforming before final release from the manufacturing site, and no deviations are related to the reported event.The batch part is conforming before final release from manufacturing site, no deviations are related to the reported event.A visual inspection of this device shows this event does not differ from previous reported events for the oxford uni spherical cutter small as a result there is no change to the severity or occurrence for this event with the reported event is still considered to be within the severity of the rmf.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.

Event Description

It was reported that the doctor has reported that the reamer (spherical cutter) is not performing as required, and has requested a replacement.Excess force had to be applied for the reamer to cut.No delay reported.No harm of the patient or the user reported.

• Brand Name: OXF UNI PH3 SPH CUTTER SML ALL
• Type of Device: KNEE ARTHROPLASTY
• 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: 11482923
• MDR Text Key: 244539827
• Report Number: 3002806535-2021-00080
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 05019279482252
• UDI-Public: 05019279482252
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• 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: 32-420329
• Device Lot Number: ZB151001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1