MAUDE Adverse Event Report: ZIMMER, INC. GRIP TIB TRAY IMPACT 3.5MM HEX; KNEE INSTRUMENT

Catalog Number 82015627600

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/19/2016

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that during the procedure a broken component on the instrument caused blue plastic to shear off and fall into the patient.

Manufacturer Narrative

This report will be amended when our investigation is complete.Returned, not yet evaluated.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.As received pad won't assemble flush to the top plate.The pin in top plate hits the shaft of the slide as it has migrated too far into the impactor head.Dhr was reviewed and no discrepancies 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.This is a known risk of the procedure as per risk documentation.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: GRIP TIB TRAY IMPACT 3.5MM HEX
• Type of Device: KNEE INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5732000
• MDR Text Key: 47594676
• Report Number: 0001822565-2016-02069
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2017

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 Catalogue Number: 82015627600
• Device Lot Number: 97011287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2016
• Initial Date FDA Received: 06/17/2016
• Supplement Dates Manufacturer Received: Not provided; 10/23/2017
• Supplement Dates FDA Received: 09/13/2016; 10/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other