MAUDE Adverse Event Report: ZIMMER BIOMET, INC. TIBIAL IMPACTOR PAD

Model Number N/A

Device Problem Disassembly (1168)

Patient Problem No Information (3190)

Event Date 05/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required as no were trends 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 that, during a procedure, the tibial impactor pad disassociated from the tibial impactor handle and fell into the joint space.The procedure was completed by retrieving the pad and putting the pad back on.No patient impact was reported.

Manufacturer Narrative

(b)(4).Upon reassessment of the reported event, it was determined an mdr should not have been filed under the current mfr number.This event will be reported on 0001825034-2018-01009.

• Brand Name: TIBIAL IMPACTOR PAD
• Type of Device: IMPACTOR
• 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: 7243786
• MDR Text Key: 99097852
• Report Number: 0001822565-2018-00728
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 42539909100
• Device Lot Number: 63517759
• Other Device ID Number: (01) 00880304810242
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• 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
• Patient Outcome(s): Required Intervention