MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PREMIER TIBIAL PUNCH TOWER MOD; PUNCH, FEMORAL NECK

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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 punch tower broke.There was no patient injury.

Manufacturer Narrative

(b)(4).The reported event was confirmed by review of actual device received.Device history record (dhr) was reviewed with no deviations identified.Based on the available information, root cause can be determined as normal wear during the instrument's field life.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

No further event information available at the time of this report.

• Brand Name: PREMIER TIBIAL PUNCH TOWER MOD
• Type of Device: PUNCH, FEMORAL NECK
• 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: 7751289
• MDR Text Key: 116090300
• Report Number: 0001825034-2018-04543
• Device Sequence Number: 1
• Product Code: HWP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 32-487269
• Device Lot Number: ZB090227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/18/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 12/26/2018
• Supplement Dates FDA Received: 01/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1