MAUDE Adverse Event Report: BIOMET UK LTD. OXF FEM TRIAL REMOVER; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported, that: the operation was performed with the oxford system on (b)(6) 2022.During the procedure, the spring that is hooked to the claw on the tip of the remover was broken.The broken piece was lost, but the postoperative x-ray showed a metal fragment.Patient involvement- further outcome unknown.

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).The 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: the operation was performed with the oxford system on feb 21, 2022.During the procedure, the spring that is hooked to the claw on the tip of the remover was broken.The broken piece was lost, but the postoperative x-ray showed a metal fragment.Patient involvement- further outcome unknown.Addi received on 14 mar 2022: - will there be further surgery to remove the fragment?: no.- is the lot number available? : it is difficult to read it, so please check it against the manufacturing records on your side.- delay: no.- any variance from the expected surgical technique: no.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the investigation has been limited to the information provided, and a complaint history search.A review of the device history records could not be carried out as the dhr has not been found.A review of complaint history identified 5 additional similar complaints about the reported item and no additional complaints about the reported item and lot combination.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the instrument is not within the scope or subject of any capas, field actions or recalls which could be attributed to the reported event.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.Corrective action and/or preventative action: no corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the investigation has been limited to the information provided, and a complaint history search.A review of the device history records could not be carried out as the dhr has not been found.A review of complaint history identified 5 additional similar complaints about the reported item and no additional complaints about the reported item and lot combination.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.It has been confirmed that the instrument is not within the scope or subject of any field actions or recalls which could be attributed to the reported events.The likely condition of the device when it left zimmer biomet is conforming to the specification.The reported event has not been confirmed as relevant photographs have not been provided and the product has not been returned for evaluation and the dhr review did not identify any issues.The root cause of the reported event cannot be determined with the information provided.The product has now been returned: visual inspection of the device confirms the reported event.The instrument has been in the field for approximately 20 years and appears in good condition for its age.Lot # e2 18161 suggests that the manufacturing date was sometime in 2002 and the manufacturer was eurocut.Eurocut was acquired by sandvik medical solutions in 2008 and no manufacturing data is available prior to 2008.A review of the x-ray appears to show the fractured piece of the spring in the patient.The definitive root cause of this event cannot be determined with the available information; however, wear and tear may have been a contributing factor.Corrective action and/or preventative action: no corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported, that: the operation was performed with the oxford system on (b)(6) 2022.During the procedure, the spring that is hooked to the claw on the tip of the remover was broken.The broken piece was lost, but the postoperative x-ray showed a metal fragment.Patient involvement- further outcome unknown.Addi received on 14 mar 2022.- will there be further surgery to remove the fragment?: no.- is the lot number available? : it is difficult to read it, so please check it against the manufacturing records on your side.- delay: no.- any variance from the expected surgical technique: no.

• Brand Name: OXF FEM TRIAL REMOVER
• 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: 13665711
• MDR Text Key: 289271714
• Report Number: 3002806535-2022-00089
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 05019279477234
• UDI-Public: 05019279477234
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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: 32-420126
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1