MAUDE Adverse Event Report: BIOMET UK LTD. NON MODULAR TIBIAL TRAY IMPACTOR (CEMENTLESS APPLICATION); OXFORD MICROPLASTY INSTRUMENTS

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 05/30/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source - foreign: canada.Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It was reported that during the unicompartmental knee surgery the instrument's back tab wasn't fixed anymore.The surgery was prolonged by 5 minutes and completed with another device.No other known impact or consequence to the patient.Due diligence is in progress for this complaint; to date no additional information or product has been received.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, d9, g3, g6, h1, h2, h3, h6, h10.Visual examination of the returned product confirms the fixed foot has fractured from the main body.The product was returned dismantled and not complete.Two screws and the blue pad were missing.The instrument exhibits indentations on the top of the main body suggesting excessive use of the toffee hammer during insertion/impaction.The instrument has been potentially used in the field for approximately 5 years and 6 months.The reported event does not indicate a manufacturing issue.No further investigation action will be required as the additional information does not affect the previously completed investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

Manufacturer Narrative

(b)(4).Visual examination of the provided pictures identified the hook had partially sheared from the body of the instrument.Review of the device history records identified no deviations or anomalies during manufacturing.Medical records were not provided however, the complaint description describes minor surgical delay whilst an alternative instrument is sourced without further discussion on further outcome.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

No further event information available at the time of this report.

• Brand Name: NON MODULAR TIBIAL TRAY IMPACTOR (CEMENTLESS APPLICATION)
• Type of Device: OXFORD MICROPLASTY INSTRUMENTS
• 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: 14851619
• MDR Text Key: 302365225
• Report Number: 3002806535-2022-00278
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(10)ZB160807
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P010014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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: 32-422097
• Device Lot Number: ZB160807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1