MAUDE Adverse Event Report: BIOMET UK LTD. OXF CMNTLS IMPLANT INSERT; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problems Fracture (1260); Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product is in process of being 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 after the impaction of the tibia, it was noticed that one of the hook that holds the implant was all bent.Once impaction was completed, the hook was removed by hand.No impact to patient reported.

Event Description

It was reported that after the impaction of the tibia, it was noticed that one of the hook that holds the implant was all bent.Once impaction was completed, the hook was removed by hand.No impact to patient reported.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the investigation was limited to a review of the complaint history and dhr/raw material certificates ((b)(4) dhr review) as the reported product was not returned or photographs of the reported event were available for review.Without the opportunity to examine the complaint product, a definitive root cause cannot be determined due to insufficient information.However, possible misuse scenarios such as excessive tightening of the thumbwheel or the application of a bending load when trying to disengage which could subject the posterior tab to excessive reactionary forces could be contributing factors.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to reported event.A review of the complaint database over the last 3 years has found 32 similar complaints reported with the item 32-422097 and there are 30 complaints of similar issue for which (b)(4) had been raised initially to investigate the issue and determine no breach against remediated risk file however,(b)(4) was initiated to assess whether additional complaints impacted the occurrence rate in risk file.The outcome of (b)(4) states that capa/scar was not recommended.All occurrences are within the acceptable level determined by the latest version of the risk matrix for this device.The severity and occurrence rate of the reported event is deemed to be in line with the risk file.The risk is deemed to be low.The investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and further investigated.Item not returned.

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 and corrected information.Visual examination of the returned product confirms the fixed foot has fractured.The fractured piece was not returned with the product.The product was returned dismantled and not complete.Three screws, blue pads and the side plate were missing.The instrument exhibits indentations on the top of the main body suggesting excessive use of the toffee mallet during insertion/impaction.There is also evidence of indentations on the back side of the instrument suggesting use of the toffee mallet in the anterior to posterior direction.The instrument has been in the field for approximately 7 years.Review of the device history record(s) 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: OXF CMNTLS IMPLANT INSERT
• Type of Device: BMET GENERAL KNEE 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: 12768711
• MDR Text Key: 281286144
• Report Number: 3002806535-2021-00486
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2022

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: 32-422097
• Device Lot Number: ZB150602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 12/21/2021; 09/26/2022
• Supplement Dates FDA Received: 12/22/2021; 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1