MAUDE Adverse Event Report: BIOMET FRANCE S.A.R.L. AVANTAGE THREAD SHAFT STRAIGHT; AVANTAGE THREAD SHAFT STRAIGHT HT

Model Number N/A

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source: event occurred in (b)(6).Recall: zfa2018-00369 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 the product was broken.

Event Description

It has been reported that the product was broken.

Manufacturer Narrative

(b)(4).This follow-up report is being submitted to relay additional information.The device manufacturing quality record indicates that the released product met all requirements to perform as intended.Products were returned to zimmer biomet and the breakage on the avantage thread shaft straight was confirmed by research and development.The root cause was assessed as related to the device design.A corrective action was initiated on the avantage thread shaft straight to investigate and take appropriate actions.Moreover, a recall was performed on avantage thread shaft straight, reference (b)(4).No device in the scope of the recall had been distributed to the usa.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.

• Brand Name: AVANTAGE THREAD SHAFT STRAIGHT
• Type of Device: AVANTAGE THREAD SHAFT STRAIGHT HT
• Manufacturer (Section D): BIOMET FRANCE S.A.R.L.; plateau de lautagne bp75; valence cedex 26903 ; FR 26903
• MDR Report Key: 8463975
• MDR Text Key: 145984413
• Report Number: 3006946279-2019-00189
• Device Sequence Number: 1
• Product Code: KWY
• UDI-Device Identifier: 00880304732940
• UDI-Public: (01)00880304732940
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

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: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 110027769
• Device Lot Number: 120200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1