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

Model Number N/A

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Initial report.Report source: foreign - event occurred in (b)(6).Patient information is not allowed by country regulations.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 Description

It was reported that during the surgery, the spring in the slap hammer was loose and could not hold the instrument properly.The surgery finished without any delay.No impact or consequences to the patient or the user.

Event Description

It was reported that during the surgery, the spring in the slap hammer was loose and could not hold the instrument properly.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.In addition, we have not been provided with any supporting documentation which could provide additional information.Mhr review could not be performed as lot number is unknown.A review of the complaint database over the last 3 years has found 21 complaints reported with these items.The risk management report documents the estimated residual risk associated with cemented oxford partial knee system.The severity of the reported event is in line with the risk file, and the calculated occurrence rate for all similar events in the last 3 years is also in line with the risk file.Without the opportunity to examine the complaint product, root cause cannot be determined due to insufficient information.If any additional information becomes available, then the complaint will be reopened and investigated thoroughly.Product not returned.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Product has been returned and as a result the lot number has been identified.The investigation is in progress.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during the surgery, the spring in the slap hammer was loose and could not hold the instrument properly.The surgery finished without any delay.No impact or consequences to the patient or the user.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Product has been returned.A visual check of the returned product oxford femoral slap hammer (item 32-422365, lot.Zb171201) confirms that the spring has fractured and is no longer attached to the spring retaining pin.A dimensional inspection is not required for this event as this reported event is for a fractured spring.The most likely cause of the fractured spring in the oxford femoral slap hammer is wear and tear as there is evidence of wear and damage on all the surfaces, this suggests that this instrument has been used for many procedures and sterilisation cycles since it was manufactured in 2018.This product left zimmer biomet control conforming.Investigation is completed based on current available information.If any additional information becomes available, then the complaint will be reopened and investigated.

Event Description

It was reported that during the surgery, the spring in the slap hammer was loose and could not hold the instrument properly.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: 11647593
• MDR Text Key: 246003341
• Report Number: 3002806535-2021-00112
• 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,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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: ZB171201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1