MAUDE Adverse Event Report: BIOMET UK LTD. OXF UNI TOFFEE HAMMER; KNEE ARTHROPLASTY

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the product was broken.
Additional Manufacturer Narrative
(b)(4).Complaint summary: products have been returned to biomet uk ltd for evaluation and forwarded to the complaints processing unit for investigation.The complaint states, hammer fractured at joint to head.This event did not occur during surgery.No health consequences or impact.Review of returned product confirms that shaft has fractured.Visual inspection confirmed that the shaft has fractured below the head of the hammer head.The instrument shows signs of considerable wear (mushrooming) and indentations on the hammer head.This is most likely due to repeated use and time in the field (approximately 8 years and 4 months).Dimensional check not required as this does not impact the complaint.The instrument is assembled in conformance to specification.The root cause cannot be confirmed with the available information however, the likely root cause of the reported event is end of useable lifespan of the instrument which has been in the field for approximately 8 years and 4 months.The controls outlined within the reusable instrument lifespan 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 below.1.Instruments should be inspected for completeness and function.2.Inspection includes: a.Checking instruments that form part of a larger assembly or assemble with mating components.B.Checking internal mechanisms such as o-rings, springs, and subcomponents, if the device is intended to be disassembled for proper reprocessing.C.Actuating moving parts such as hinges/joints and moveable features such as handles, ratcheting, couplings, and sliding parts.D.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.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.Review of dhr confirms approval of final release of product in line with compliance with the specification and regulation requirements, and therefore confirms that the product left the company conforming.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.A review of the complaint database over the last 3 years did not show any capa or hhed associated to this complaint category.No corrective action required at this time.Both the severity and occurrence of the reported event are in line with the risk file.No harm to patient has been reported.The item was distributed conforming.Adequate instructions are provided to ensure the instrument is reprocessed correctly.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.Capa: no corrective or preventive action required at this time.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that the product was broken.

• Brand Name: OXF UNI TOFFEE HAMMER
• Common Device Name: KNEE ARTHROPLASTY
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11830778
• Report Number: 3002806535-2021-00192
• Device Sequence Number: 4129254
• Product Code: HWA
• UDI-Device Identifier: 00880304525658
• UDI-Public: 00880304525658
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2021

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: ZB130303
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 07/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• 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