MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LOCK SCREW SQUARE 2.7MM X 12MM; PROSTHESIS, TRAUMA

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This report is being submitted late as it has been identified in remediation.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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 by the hospital that the locking peg was missing from the packaging when it was received.This was not involved in a surgery.No patient involvement.No adverse event has been reported as a result of this malfunction.

• Brand Name: LOCK SCREW SQUARE 2.7MM X 12MM
• Type of Device: PROSTHESIS, TRAUMA
• 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: 6954094
• MDR Text Key: 90482219
• Report Number: 0001825034-2017-08792
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• 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: 131227112
• Device Lot Number: SBM057955
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2015
• 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