MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS MED 3MM; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

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

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign: event occurred in (b)(6).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 during surgery, the instrument broke off when it was taken out of the knee, nothing fell into the patient, and no harm was done to the patient.The surgeon was able to finish the surgery without any delay.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: lot number: zb111203.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during surgery, the instrument broke off when it was taken out of the knee, nothing fell into the patient, and no harm was done to the patient.The surgeon was able to finish the surgery without any delay.

Event Description

It was reported that during surgery, the instrument broke off when it was taken out of the knee, nothing fell into the patient, and no harm was done to the patient.The surgeon was able to finish the surgery without any delay.

Manufacturer Narrative

(b)(4) this follow-up report is being submitted to relay a correction the following sections were updated: b4, b5, d4, g3, h1, h2, h10 correct lot number identified: lot number: zb14120 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h1, h2, h3, h6, h10.Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.Visual inspection of the returned part confirms that there is a fracture of the bottom face and one side has a piece of the material missing.The instrument shows signs of wear & tear, with evidence of surface scratches which are in line with repeated use and reprocessing during its time in field (approximately 6 years).Due to the time in the field and evidence of repeated use, without complaint, there is no suggestion that a dimensional non-conformance would have an impact on the reported event.Assembly check not conducted as device was returned damaged.A review of the raw material certificates confirm that the material was conforming to specification before final release.A review of the manufacturing history records shows that the certificate of conformance confirms that the device was processed and verified in line with the specification and quality characteristics as defined by zimmer biomet before final release.The product (item 32-422703, lot zb141203) has not been involved in any previous field actions.No corrective/preventive actions are deemed necessary at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm to patient has been reported.The item was distributed conforming.Adequate instructions are provided to ensure the instrument is reprocessed correctly.The root cause cannot be confirmed with the available information however, the likely root cause of the reported event is due to repeated assembly and disassembly over several years of use as well as reprocessing through cleaning/sterilisation systems.This is in line with the end of usable life of the instrument which has been in the field for approximately 6 years and shows signs of wear and tear due to repeated use.The hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered to be low.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 during surgery, the instrument broke off when it was taken out of the knee, nothing fell into the patient, and no harm was done to the patient.The surgeon was able to finish the surgery without any delay.

• Brand Name: OXF TRL BRG W/SLOTS MED 3MM
• 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: 12230868
• MDR Text Key: 265599506
• Report Number: 3002806535-2021-00326
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 05019279346813
• UDI-Public: 05019279346813
• Combination Product (y/n): N
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• 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: 32-422703
• Device Lot Number: ZB141203
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1