MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TOFFEE HAMMER; BMET GENERAL KNEE INSTRUMENTS

Model Number N/A

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

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).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 hammer has broken in half while impacting the femoral trial.No patient involvement.

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 as the reported product was not returned, no photographs of the reported event or lot number for dhr were made available for review.Without the opportunity to examine the complaint product, a definitive root cause cannot be determined due to insufficient information.However, a possible lack of fusion of the weld joint and repeated use could be contributing factors for the instrument fracture.The issue relates to an instrument therefore an implants compatibility check is not required.A dhr review could not be performed as the lot number has not been provided.A review of complaint history identified 13 similar complaints about the reported item number in the last 3 years.Item and lot combination search could not be conducted as lot number has not been provided.Reports were previously initiated to address the issue that the welding process is not validated in jinhua, china.A complaint search was conducted for the affected 95 skus.After analysis of the complaint data, it was found that the occurrence rates are below the occurrence rate of 2 specified.It has an occurrence rate of 2 (0.01% < p < 0.10%) for line 30, welding is not performed on the specified area/incomplete fusion, which leads to medical device fractured during surgery, and surgery being delayed.Per the decision process followed in the containment decision process, this is a potential product non-conformity, it does have an impact on the final product form, fit, function or intended use, however, this is not a complaint about a confirmed out of box failure, the risk level for the product failure mode in the rmf is accurate, and the occurrence rate for the product failure mode is below the acceptable rate defined in the rmf, thus, no product containment required.The reported item in this complaint, 32-422760, is included in the scope of the capa.The risk associated with the reported event is addressed in cemented instruments risk table rev 8 risk tables ¿ has a severity score of 1 as the surgical intervention was not required and an occurrence rate of 3 (occasional, greater than 1 in 1,000 and less than 1 in 10,000).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.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 hammer broke in half while impacting the femoral trial.No patient involvement.Addi received on 1 dec 2021 it is a weld fracture.

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/or corrected information.Visual examination of the returned product identified that the weld between the handle and shaft has cracked around its circumference.The handle is now loose in relation to the shaft.The toffee hammer has been used extensively identified by peening and heavy indentations on the impact face of the hammer head.The hammer has potentially been in the field for approximately 8 years.Review of the device history records identified no deviations or anomalies during manufacturing.Device is used for treatment.A definitive root cause cannot be determined.Capa was previously initiated to address the issue that the welding process is not validated in jinhua, china.Additionally, there was a previous hhe which assessed the health risk of a non validated weld.This did not result in a field safety corrective action or product hold.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 UNI TOFFEE HAMMER
• 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: 12882348
• MDR Text Key: 282707219
• Report Number: 3002806535-2021-00515
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00880304525658
• UDI-Public: (01)00880304525658(11)141011(10)ZB140901
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• 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: 32-422760
• Device Lot Number: ZB140901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1