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

Model Number N/A

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

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

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Patient information is not allowed by country regulations.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product is available to be returned to zimmer biomet for investigation.(b)(6).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 locking pin in the oxford cutting guide was lost in the operating room.All fractured pieces were retrieved.No harm to patient.No delay to surgery.

Event Description

It was reported that the locking pin in the oxford cutting guide was lost in the or.All fractured pieces were retrieved.No harm to patient.No delay to surgery.

Manufacturer Narrative

(b)(4).Complaint summary: it was reported that the locking pin in the oxford cutting guide was lost in the or.It was reported that the locking pin in the oxford cutting guide was lost during surgery.A new procedure was required to remove the piece of metal from the patient's knee which was carried out later the same week.An oxford femoral posterior cutting guide (item: 32-422981, lot: zb171101) was sent to the research department for evaluation after the 2.5 x 6 mm pin detached during surgery, after a maximum period of approximately 3 years and 3 months in service.Minor scratches and indentations were observed over the main body of the oxford femoral posterior cutting guide, which are indicative of its repeated use.The 2.5 x 6 mm pin was received detached from the main body of the instrument.This was reported to have fallen into the patient¿s wound when the instrument was used, and additional surgery was required to retrieve the part.The provided mhrs and complaint investigation form confirm that the instrument was manufactured in accordance with the applicable specifications.Based on the information provided, it appears that the failure of the oxford femoral posterior cutting guide reported with cmp-0678235 can be ascribed to general wear due to its repeated use and reprocessing.A review of the complaints data base for 3 years prior to the notification date has found three similar reported events for this item (including initiating complaint).The risk associate with the reported event is addressed in the cementless oxford partial knee risk file.The severity of the reported event is in line with the risk file, and no issue with the occurrence rate has been identified.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).This follow up report is submitted to correct an error.We previously reported the name of healthcare facility where incident occurred as (b)(6).We have since identified the healthcare facility as (b)(6).However, the address of the healthcare facility and contact details remain the same.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 locking pin in the oxford cutting guide was lost during surgery.A new procedure was required to remove the piece of metal from the patient's knee which was carried out later the same week.Attempts have been made and no further information has been provided at this time.

• Brand Name: OXF MP SLOT POST CUT GD MED
• Type of Device: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11573796
• MDR Text Key: 245198381
• Report Number: 3002806535-2021-00092
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 05019279440023
• UDI-Public: 05019279440023
• 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,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422981
• Device Lot Number: ZB171101
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention