MAUDE Adverse Event Report: BIOMET UK LTD. OXF GAP GAUGE SML 3/4MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as it has been discarded.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 oxford gap gauge, small-3/4, snapped in half and needs to be replaced.It was not needed for the rest of the case, there was no need for resolution at the time.
Additional Manufacturer Narrative
(b)(4).This final report is being submitted to relay additional information.Complaint summary: as the product has not been returned for review and evaluation, the investigation was limited to the information provided, a review of device history records and complaint history.In addition, we have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 1 complaint reported with the item (b)(4) (initiating complaint).There is evidence of significant wear and tear on the gap gauge which indicates heavy or prolonged usage.Instruction for required instrument inspection/function testing captured in the reusable instrument lifespan manual states: 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.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information, furthermore, the supplied photograph only shows the item is fractured but it does not yield any information that could identify the cause.However, the most likely root cause is misuse by the user.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.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.H3 other text : discarded.
Event or Problem Description
It was reported that the oxford gap gauge, small-3/4, snapped in half and needs to be replaced.It was not needed for the rest of the case, there was no need for resolution at the time.

• Brand Name: OXF GAP GAUGE SML 3/4MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET UK LTD.; waterton industrial estates; bridgend CF31 3XA; UK CF31 3XA
• MDR Report Key: 11972781
• Report Number: 3002806535-2021-00248
• Device Sequence Number: 1153340
• Product Code: HXC
• UDI-Device Identifier: 00880304525382
• UDI-Public: 00880304525382
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: 32-422801
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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