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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that: the dr.Was impacting the femur and the toffee hammer broke.There was no harm to the patient or delay in the case another hammer was used to finish the case.Patient involvement- no further outcome.
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
(b)(4).Initial report.The client has indicated that the product will not be returned to zimmer biomet for an investigation.The investigation is currently underway.Once the investigation has concluded, a follow-up mdr will be submitted.
Event or Problem Description
It was reported, that: the dr.Was impacting the femur and the toffee hammer broke.There was no harm to the patient or delay in the case another hammer was used to finish the case.Patient involvement- no further outcome.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the device is used in treatment.A review of returned products confirms that the instrument has fractured.Visual inspection of the toffee hammer (32-422760 oxf uni toffee hammer zb130409) shows that the instrument has fractured at the point where the shaft meets the hammerhead.The instrument shows signs of wear with mushrooming and indentations on the hammerhead.This is most likely due to repeated use over time in the field (approximately 9 years).Review of material certificates confirms conformance to specification.The dhr related to the involved product has been reviewed and does not show any non-conformity, rejection or concession that could be related to the reported event.The product was most likely conforming when it left zimmer biomet control.The mhr related to the involved product has no non-conformances.The product item.32-422760 and lot: zb130409 has not been involved in any previous field actions.No corrective or preventive action is considered necessary at this time.The definitive root cause cannot be determined with the available information however, the instrument has been in the field for approximately 9 years the repeated use and reprocessing is likely to be a contributing factor to the end of the useable lifespan of the instrument.The controls outlined in the manual informs the user of the following inspection and testing instructions to ensure the condition of the instruments are regularly monitored and assessed during the reprocessing operation: inspection/function testing.While loading instruments into their respective instrument cases after cleaning and prior to sterilization, reference the manual and follow the instructions: (1 - instruments should be inspected for completeness and function.2 - inspection includes: checking instruments that form part of a larger assembly or assemble with mating components.Checking internal mechanisms such as o-rings, springs, and subcomponents, if the device is intended to be disassembled for proper reprocessing.Actuating moving parts such as hinges/joints and moveable features such as handles, ratcheting, couplings, and sliding parts.Inspecting for all forms of wear outlined in this manual.3 - results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.4 - if the reusable instrument is determined no longer suitable for use or if the suitability for use is still in question after inspecting the instrument and referencing the reusable instrument lifespan manual, initiate the process to return the instrument(s) to the manufacturer.) the severity of the reported event and calculated occurrence for similar complaints are in line with and do not exceed the risk referenced in the risk management file.The overall score is low risk.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 or Problem Description
It was reported, that: the doctor was impacting the femur and the toffee hammer broke.There was no harm to the patient or delay in the case another hammer was used to finish the case.Patient involvement - no further outcome.

• Brand Name: OXF UNI TOFFEE HAMMER
• Common Device Name: 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: 13497245
• Report Number: 3002806535-2022-00058
• Device Sequence Number: 17172167
• Product Code: HWA
• UDI-Device Identifier: 00880304525658
• UDI-Public: 00880304525658
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 32-422760
• Device Lot Number: ZB130408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2013
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown