MAUDE Adverse Event Report: BIOMET 3I 2.1 GEMLOCK,HEX TOOL,RATC; DRIVER

Catalog Number CHRL2.1

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the hex driver could not retain the implant correctly.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined this mdr was not filed under the correct mfr number.This event will be reported on (b)(4).

Event Description

Correction.

• Brand Name: 2.1 GEMLOCK,HEX TOOL,RATC
• Type of Device: DRIVER
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 8875687
• MDR Text Key: 153845746
• Report Number: 0001038806-2019-00845
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2019

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 Catalogue Number: CHRL2.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 08/08/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 08/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1