MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE CURVED HANDLE SHAFT

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).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 a workshop in order to know how to use the instrument, in some items defects have been detected.The avantage straight impact plate get stuck in the curved handle.The avantage straight impact plate thread as well as the curved shaft thread could not be disassembled.No patient or healthcare professionals were involved.

Manufacturer Narrative

(b)(4).Concomitant medical products - avantage thread shaft straight, ref: 110027769, lot : 120200.This follow-up report is being submitted to relay additional information.The device manufacturing quality record could not be reviewed as the item and lot number of the product were not communicated.Complaint sample was evaluated and investigation on the product did not show any non-conform results.The investigation showed that the most likely root cause of the event is the design of the associated item avantage thread shaft straight, ref: 110027769, lot: 120200 (handled in the complaint (b)(4)).Therefore, a corrective action has been initiated to investigate the event, and a recall was performed on the avantage thread shaft straight.Please note that no devices involved in the recall were delivered to the usa.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 was reported that during a workshop in order to know how to use the instrument, the avantage straight impact plate get stuck in the curved handle.The avantage straight impact plate thread as well as the curved shaft thread could not be disassembled.No patient or healthcare professionals were involved.

• Brand Name: AVANTAGE CURVED HANDLE SHAFT
• Type of Device: AVANTAGE CURVED HANDLE SHAFT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8464981
• MDR Text Key: 140606571
• Report Number: 3006946279-2019-00199
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• 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: 110031338
• Device Lot Number: 946870
• 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: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1