MAUDE Adverse Event Report: BIOMET ORTHOPEDICS PREMIER TIBIAL PUNCH TOWER MOD; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 08/15/2016

Event Type  malfunction  

Manufacturer Narrative

Add'l pro code- hwp.Review of device history records found these units were released to distribution with no deviations or anomalies.Product likely left zimmer biomet conforming.Visual inspection of the product determined that the tower body stem was fractured.The stem appears to have experienced excessive force however, a root could not be determined.This device is used for treatment.

Event Description

It was reported that the tibial punch tower fractured during use.The patient did not retain a foreign body.

• Brand Name: PREMIER TIBIAL PUNCH TOWER MOD
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6321610
• MDR Text Key: 67384354
• Report Number: 0001825034-2017-00583
• Device Sequence Number: 1
• Product Code: HWP
• Combination Product (y/n): N
• Reporter Country Code: AA
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2017

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: 122780
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2008
• 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