MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE STRAIGHT IMPACT PLATE

Model Number N/A

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Recall zfa2018-00374 was performed on the affected item.This item was not delivered to the usa.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 workshop with surgeons in order to know how to use the instrument, in some items defects have been detected.The avantage straight impact plate got stuck in the curved handle the avantage straight impact plate thread as well as the curved shaft thread are defective and cannot be disassembled no patient or healthcare professionals have been involved.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.Recall was performed on the affected item.Please note that the items in the scope of this recall were not delivered to the usa.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Complaint sample was evaluated and investigation on the product did not show any non-conform results.According to the available data, the root cause of the event is related to design.Corrective action was initiated to investigate the described event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It has been reported that during the workshop with surgeons in order to know how to use the instrument, the avantage straight impact plate got stuck in the curved handle.The avantage straight impact plate thread as well as the curved shaft thread are malfunctioned and cannot be disassembled.No patient or healthcare professionals have been involved.

• Brand Name: AVANTAGE STRAIGHT IMPACT PLATE
• Type of Device: AVANTAGE STRAIGHT IMPACT PLATE
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8464410
• MDR Text Key: 143814065
• Report Number: 3006946279-2019-00197
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 110028874
• Device Lot Number: 191750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1