MAUDE Adverse Event Report: BIOMET UK LTD. OXF KNEE PH3 I/M ROD RMVL HK; 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 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 during surgery the hook of instrument broke off when surgeon went to pull the rod out of the femur.
Event or Problem Description
It was reported that during surgery the hook of instrument broke off when surgeon went to pull the rod out of the femur.
Additional Manufacturer Narrative
(b)(4).Complaint summary: the complaint states, it was reported that during surgery the hook of instrument broke off when surgeon went to pull the rod out of the femur.The part was found.No patient harm and no surgical delay.This event occurred during surgery.No health consequences or impact.Review of returned product confirms that the instrument (d32-401111 rev k oxf knee ph3 im rod rmvl hk) is damaged and that the large pin (d32-401111-2 rev g oxf knee ph3 im rod rmvl hk large pin) is missing.Visual inspection of the reported event confirms that the removal hook is damaged and that the large pin (d32-401111-2 rev g oxf knee ph3 im rod rmvl hk large pin) has fractured.The instrument show signs of wear and tear which is in line with repeated use and time in field (approximately 15 years and 2 months).Dimensional check was not carried out as dimensional non-conformance does not have any impact on the reported event.No assembly checks were carried out as product is not part of an assembly and the fractured component was not returned.As the instrument has been operational in the field for an extended period it is deemed to have been functional and without any non-conformance before failure.The root cause cannot be confirmed with the available information however, the likely root cause of the reported event is end of useable lifespan after having been in the field for approximately 15 years and 2 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.If any additional information becomes available, then the complaint will be reopened and investigated.A review of the manufacturing history record (dhr item 32-401111 lot 336790) confirms that all operations and required inspections were carried out as per specification and suggests that the product left zb conforming to specification.Review of the manufacturing history record (dhr item 32-401111 lot 336790) does not show any history of any non-conformances during the manufacture of the product.As the instrument has been operational in the field for an extended period it is deemed that the material was conforming to specification on final release from the zb manufacturing site and without any non-conformance before failure.Sterile certificate review is not required as the instrument was supplied as unsterilized.A review of the complaint database over the last 3 years did not show any capa or hhed associated to this complaint category.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 hazard and reported harm are covered by the risk file and the severity/occurrence and the risk scores are within acceptable limits.The overall risk is considered to be low.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.

• Brand Name: OXF KNEE PH3 I/M ROD RMVL HK
• 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: 11973190
• Report Number: 3002806535-2021-00249
• Device Sequence Number: 1153341
• Product Code: HXC
• UDI-Device Identifier: 05019279469246
• UDI-Public: 05019279469246
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/29/2021

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: 32-401111
• Device Lot Number: 336790
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/29/2021
• 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
• Patient Age: 57 YR