MAUDE Adverse Event Report: BIOMET UK LTD. TINBN VG INT CR ANAT FM R 70M

Catalog Number 183012TNBN

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source, foreign - event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

The customer complained that the inner package is damaged.

• Brand Name: TINBN VG INT CR ANAT FM R 70M
• 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: 7797125
• MDR Text Key: 241265250
• Report Number: 3002806535-2018-00983
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Catalogue Number: 183012TNBN
• Device Lot Number: 3268296
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/04/2018
• Initial Date FDA Received: 08/20/2018
• Date Device Manufactured: 05/20/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1