MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI I/M ROD LINK; ORTHOPAEDIC IMPLANT AIMING ARM

Model Number N/A

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

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.The instrument has been 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 the instrument broke during surgery.No delay of the surgery reported.No consequences or impact to the patient, or the user reported.

Event Description

It was reported that the instrument broke during surgery.No delay of the surgery reported.No consequences or impact to the patient, or the user reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Product has been returned to biomet uk ltd for evaluation and forwarded to a research engineer for investigation.An oxford femoral drill guide navigation im rod link was received for evaluation due to fracture after being in service for a maximum of approximately 4 years and 6 months.The available relevant manufacturing history record indicate that the items were manufactured in accordance with the applicable specifications.Minor indentations and scratches observed on the main body of the instrument confirmed its repeated use.Visual examination of the fracture surfaces suggested a brittle mechanism of fracture.Based on the information provided, it appears that the instrument fracture reported with (b)(4) can be ascribed to general wear and damage due to use.The available mhr reviews indicate that the products were most likely conforming to design specification when they left zimmer biomet control.Risk assessment: risk management report documents the estimated residual risk associated with the reported event.An oxford femoral drill guide navigation im rod link was received for evaluation due to fracture after being in service for a maximum of approximately 4 years and 6 months.The reported event states instrument fracture.The details of the reported event do not allege that there was any patient harm or delay to surgery.Therefore, the severity is considered s-1 (negligible) as per definitions within the severity table in the attached rmr.In order to calculate the occurrence rate, sales and complaint data for this item number have been obtained, and are attached for a period of the last 3 years prior to the notification date, being october 2020.Sales (oct 2017 to oct 2020) = (b)(4) units.Complaints search was conducted for events occurring between oct 2017 to oct 2020 for item (b)(4).11 similar complaints were identified for this item number including (b)(4).Therefore, the calculated occurrence rate is 11 in (b)(4).Occurrence calculation =(b)(4).Rmf estimates = (b)(4).The outcome of this complaint is considered to be within the severity of the rmf.No corrective or preventive actions are considered 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 UNI I/M ROD LINK
• Type of Device: ORTHOPAEDIC IMPLANT AIMING ARM
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10860040
• MDR Text Key: 216894828
• Report Number: 3002806535-2020-00490
• 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): Y
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

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: 32-422822
• Device Lot Number: ZB160401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/22/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 03/17/2021
• Supplement Dates FDA Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 61 YR