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 Foreign Body In Patient (2687)

Event Date 06/16/2022

Event Type  Injury  

Event Description

It was reported that the tibial impactor broke.The broken piece of the instrument remained in the patient.Due diligence is in progress for this complaint; to date, no additional information or product has been received.

Manufacturer Narrative

(b)(4).(b)(6).Investigation of this incident is currently ongoing.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The returned oxford tibial impactor fractured at the l-shaped posterior foot used to hold oxford cementless tibial trays in place during impaction.The handle of the returned impactor presented scratches and indentations and are indicative of its repeated use.It may also indicate that the instrument was impacted during surgery in areas other than the top portion of the handle, such as at the adjuster screw/drum retainer on the anterior portion of the handle.The anterior foot of the returned impactor was also checked and signs of wear from contact with tibial trays were observed.The fracture surface of the main body of the returned oxford tibial impactor appeared irregular and featureless, thus indicating a brittle mechanism of fracture, polishing trail marks could also be observed surrounding the fracture surface.Review of the device history record identified no deviations or anomalies during manufacturing.Device is used for treatment.Medical records were not provided.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.

• 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: 15025962
• MDR Text Key: 295952018
• Report Number: 3002806535-2022-00308
• Device Sequence Number: 1
• Product Code: NRA
• UDI-Device Identifier: 00880304525672
• UDI-Public: (01)00880304525672(11)160329(10)ZB151101
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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: 32-422097
• Device Lot Number: ZB151101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female