MAUDE Adverse Event Report: ZIMMER BIOMET, INC. CANNULATED SCREWDRIVER

Model Number N/A

Device Problem Bent (1059)

Patient Problem No Information (3190)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Foreign.The event occurred in (b)(6).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.

Event Description

It was reported the screwdriver blade bent during use, causing a delay of 60 minutes.No further information has been made available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Visual analysis confirms the tip of the driver is bent, and there is minor cosmetic damage / wear throughout the surfaces of both the handle and the shank.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.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.

• Brand Name: CANNULATED SCREWDRIVER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 7086234
• MDR Text Key: 93823088
• Report Number: 0001825034-2017-10758
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: A5737
• Device Lot Number: 5295335
• Other Device ID Number: (01) 0 0887868 11661 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Manufacturer Received: 11/08/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 05/18/2018
• Supplement Dates FDA Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other