MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQUARE 2.7MM X 13MM; APPLIANCE, FIXATION

Model Number N/A

Device Problems Component Missing (2306); Out-Of-Box Failure (2311)

Patient Problem No Patient Involvement (2645)

Event Date 10/23/2014

Event Type  malfunction  

Manufacturer Narrative

Review of pictures of the returned packaging, identified a hole on backside of packaging just to the upper right of sticker number.Visual inspection of the condition of complaint product as returned, the package was missing cortical lock screw part number: 131227113, as stated in the complaint.Plastic packaging showed 3 different places where there were slight punctures with one hole large enough for the screw to fit through.Based on dhrs, the product was made to print and correct materials.Complaint history did not find any additional issues or trends.Root cause determined to be improper handling of package.Product likely wasn¿t in package due to screw had been removed through the large hole in packaging sometime after being shipped from biomet.This was not a supplier issue.Condition is addressed in the dfmea table.A summary of investigation has been sent to the complainant.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 upon receipt of product by the distributor, it was noticed that the product was missing from the package.There was no patient involvement.Attempts have been made and no further information has been provided.

• Brand Name: LOCK SCREW SQUARE 2.7MM X 13MM
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6928168
• MDR Text Key: 89509207
• Report Number: 0001825034-2017-08133
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• 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: 131227113
• Device Lot Number: SBM046773
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1