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

Catalog Number 110031338

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).Reported event was confirmed as the pictures provided show the product broken.The product evaluation showed that the avantage curved handle shaft broke at the weld between the straight part and the curved part.It is possible that the two parts were not sufficient welded or that the weld was damaged by the polishing.Therefore, the product evaluation confirmed the reported event and the most probable cause of the event is a manufacturing issue.Dhr review : the review of the device manufacturing quality record indicates that 10 products avantage curved handle shaft, reference 110031338, batch 056790 were manufactured on 01 february 2018.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.No non conformity or deviation was observed which could be linked to the event described in the complaint.Only this complaint has been recorded for avantage curved handle shaft, batch 056790 within one year.According to available data, the most probable root cause could be a manufacturing issue.A summary of the investigation was sent to the complainant conveying zimmer biomet conclusions; 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 the surgery the instrument was broken due to impaction.No adverse event was reported due to the malfunction.

• Brand Name: AVANTAGE CURVED HANDLE SHAFT
• Type of Device: HIP, INSTRUMENT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer (Section G): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 11363991
• MDR Text Key: 234445563
• Report Number: 3006946279-2019-00562
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 110031338
• Device Lot Number: 056790
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 70