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

Model Number N/A

Device Problems Mechanical Problem (1384); Unstable (1667); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

Cmp (b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Patient information is not allowed by country regulations.Postal code: (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery, the doctor complained that the tip that is supposed to hold instruments was moving around and was not efficient.The surgery finished without any delay.No impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4) this final report is being submitted to relay additional information.Due to circumstances surrounding the covid-19 pandemic, complaint product return cannot be performed at this time.Therefore, the complaint investigation will proceed with currently available information.Should the complaint product become available, the complaint investigation will be updated as appropriate.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.A review of the complaint database over the last 3 years has found 4 similar complaints reported with these item for instrument function problem.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.Risk assessment: root cause: the root cause of the reported event could not be determined with the information provided.The instrument has been in the field over 3 year and could have been used in many operations.Item: 32-422365 batch: zb40301 manufacture date: 07 july 2017.The reusable instrument lifespan manual provided states the following: 1.Instruments should be checked 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 assemble, 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 to be 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.Occurence rate assessment: -(b)(4) items sold the given period.-(b)(4) x 3(used 3 times per procedure) = (b)(4).-number of similar incidents identified: 4 (including initiating complaint).-occurrence ratio: (b)(4).-the calculated risk is as follows: severity of the reported event = 1 (negligible) and calculated occurrence rate of 1 (improbable) are in line with the risk file.Therefore, the overall score is low risk.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.

Event Description

It was reported that during the surgery, the doctor complained that the tip that is supposed to hold instruments was moving around and was not efficient.The surgery finished without any delay.No impact or consequences to the patient or the user.

Manufacturer Narrative

Cmp-(b)(4).Complaint summary: the complaint states: it was reported that during the surgery, the doctor complained that the tip that is supposed to hold instruments was moving around and was not efficient.They were able to finish the surgery without any delay and no harm was done to the patient.This event occurred during surgery.No health consequences or impact.A review of the complaint database over the last 3 years has found 4 similar complaints reported with these item for instrument function problem.After review of the returned instrument the complaint could not be confirmed.The instrument appeared to be in working order with appropriate tension in the claw.On visual inspection the instrument shows signs of surface scratches in line with usage and its time in the field (approximately 4 years and 6 months).The tension spring can be seen within the claw, is intact and in good working order.The instrument assembly looks, and functions, as per the drawing and design specification.Dimensional check is not required for this complaint as the component is conforming to specification and the reported event could not be confirmed or recreated.Raw material certificate review confirms ais industrial components ltd spring material is conforming.Dhr review confirms that material was deemed compliant on product release.Review of the zbiomet manufacturing history record 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.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.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 during the surgery, the doctor complained that the tip that is supposed to hold instruments was moving around and was not efficient.The surgery finished without any delay.No impact or consequences to the patient or the user.

• 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: 10903382
• MDR Text Key: 218235363
• Report Number: 3002806535-2020-00492
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: ZB40301
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2017
• 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