MAUDE Adverse Event Report: BIOMET UK LTD. OXF TRL BRG W/SLOTS SML 4MM; KNEE TIBIA TRIAL PROSTHESIS

Model Number N/A

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Customer has indicated that the product is available 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 the oxford poly trial size small 4 mm plastic piece broke when removing from patient.No harm reported.No delay reported.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: lot number received: zb160301.Product returned to zimmer biomet uk for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental mdr will be submitted.

Event Description

It was reported that the oxford poly trial size small 4 mm plastic piece broke when removing from patient.No harm reported.No delay reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.Oxford poly trial size small 4 mm plastic piece broke when removing from patient.Instrument fracture during surgery.No harm has been reported to patient.Visual checks of the returned product oxford trial bearing sz4 small (item (b)(4), lot.Zb160301) confirms that there is a fracture on both sides of the bottom face and one side has a piece of the material missing.This instrument is showing a lot of wear and tear consistent with many years of use as the instrument was manufactured in 2016.A review of the complaints database shows that we have received no reported events for instrument fracture problem for the same item number (b)(4) prior to the reported event.Risk assessment: the severity of the reported event and calculated occurrence for similar complaints are in line with the risk file the overall score is low risk.No corrective or preventive action is 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.

Event Description

It was reported that the oxford poly trial size small 4 mm plastic piece broke when removing from patient.No harm reported.No delay reported.

• Brand Name: OXF TRL BRG W/SLOTS SML 4MM
• Type of Device: KNEE TIBIA TRIAL PROSTHESIS
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 10634822
• MDR Text Key: 214804797
• Report Number: 3002806535-2020-00444
• Device Sequence Number: 1
• Product Code: NRA
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2020

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: 32-422699
• Device Lot Number: ZB160301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/16/2020; 12/01/2020
• Supplement Dates FDA Received: 11/10/2020; 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 76 YR