MAUDE Adverse Event Report: BIOMET UK LTD. OXF FEMORAL SLAP HAMMER; ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR

Model Number N/A

Device Problems Activation, Positioning or Separation Problem (2906); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Concomitant medical products: customer has indicated that the product is available to be returned to zimmer biomet for investigation.(b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that something appears to have broken in the mechanism, therefore the claws don¿t activate anymore making the instrument unusable.No clinical signs, symptoms or conditions to the patient or the user.

Event Description

It was reported that something appears to have broken in the mechanism, therefore the claws don¿t activate anymore making the instrument unusable.No clinical signs, symptoms or conditions to the patient or the user.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to make a correction.Additional information: d4: lot number is confirmed to be zb150902.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that something appears to have broken in the mechanism, therefore the claws don¿t activate anymore making the instrument unusable.No clinical signs, symptoms or conditions to the patient or the user.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.The following sections were updated: b4, b5, d10, g4, g7, h1, h2, h3, h6, h10.Attempts were made to obtain additional information; however, none was available.As the product has not been received, the investigation was limited to the information provided; a review of device history records and complaint history.We have not been provided with any supporting documentation which could provide additional information.A review of the manufacturing history records confirms no abnormalities or deviations reported, ncr issued for discoloration issue and had been accepted after rework.A review of the complaint database over the last 3 years has found 17 similar complaint reported with the item 32-422365 including the complaint (b)(4).Risk assessment: root cause: the most likely root cause is that the tension spring has fractured therefore the claws are no longer operate correctly.Occurrence rate assessment: nov 2017 to nov 2020: (b)(4) items sold.This instrument is used 3 x in surgery 3 x 285371 = 856113 mechanical characteristics of instrument degrade over time, no patient harm ¿ severity 1, occurrence 2.Number of similar complaints identified: 17 (including initiating complaint).Occurrence ratio: 1 : (b)(4).The severity of the reported event and calculated occurrence for this complaint are in line with the risk file the overall score is low risk.If further information regarding the root cause of the reported event or reason for revision are provided, the risk will be re-assessed.No corrective or preventive actions are deemed necessary at this time.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.H3 other text : product has not been returned.

Manufacturer Narrative

(b)(4).This final report is being submitted to relay additional information.Complaint summary: the complaint states: that something appears to have broken in the mechanism, therefore the claws don¿t activate anymore making the instrument unusable.This event did not occur during surgery.No health consequences or impact.The complaint has been confirmed, on review of the returned instrument it is evident the tension spring has fractured within the claw.On visual inspection the instrument shows signs of wear.The tension spring can be seen within the claw and is clearly fractured.With the exception of the spring, which is the reported event, the rest of the instrument assembly looks and functions as per the drawing and design specification.Dimensional check is not required for this complaint as the component fracture is not likely to be caused by dimensional non-conformance.The components of the instrument assembly are conforming to the specification.Review of material certificates confirm that the material for each of the instruments components were conforming to standards and specification prior to shipment to zb.A review of the manufacturing history record shows that there was one recorded non-conformance for (dhr 32-422365 zb150902- 4) during the production of the instrument for a discoloration issue, however the certificate of conformance confirms that the device was processed and verified in line with the specification and quality characteristics after rework activity was completed as defined by zimmer biomet.Ie-10329 was raised during previous investigations for similar reported events.The ie concluded that: the spring used in these slap hammer assemblies is required to provide a pre-load, in order that the instruments and trials are securely held when the slap hammer is used.It is therefore necessary to use a spring that is held in tension when the instrument jaws are closed.The working length of the spring, provided by the manufacturer, is for guidance only and does not imply a hard limit nor define that the spring cannot be safely used outside these parameters.Ie-05858 was previously opened to review spring failures relating to this instrument, and came to the conclusion that the occurrence rate and severity of harm was within the values specified by the relevant risk management documentation.Review of the occurrence and severity for the present ie shows that the occurrence and severity remain within the risk management levels.No information is presented in the current ie that would alter the conclusions of the previous ie.The manufacturer's recommended working range for the spring does not define its limits.The instrument has been in the field for approximately 6 years.The most likely root cause is that the tension spring fractured due to general wear and tear over time, but there is no definitive information that could identify the root cause.Instruction for required instrument inspection/ function testing and 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.Instruments should be inspected for completeness and function.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.Results of assembly, actuation, and extent of all forms of wear should be considered in determining whether an instrument is suitable for use.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.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 Description

It was reported that something appears to have broken in the mechanism, therefore the claws do not activate anymore making the instrument unusable.No clinical signs, symptoms or conditions to the patient or the user.

Event Description

It was reported that something appears to have broken in the mechanism, therefore the claws don't activate anymore making the instrument unusable.No clinical signs, symptoms or conditions to the patient or the user.

Manufacturer Narrative

This follow-up final report is being submitted for the following reason: paragraph referencing: (b)(4) on previously submitted report (mfr report number 3002806535-2020-00518-3) should be discarded as this was cited in error.

• Brand Name: OXF FEMORAL SLAP HAMMER
• Type of Device: ORTHOPAEDIC IMPLANT INSERTER/EXTRACTOR
• 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: 10976094
• MDR Text Key: 227214060
• Report Number: 3002806535-2020-00518
• Device Sequence Number: 1
• Product Code: HXC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• 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: 32-422365
• Device Lot Number: ZB150902
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1