MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE EZ PASS 30 DEGREE RIGHT; PASSER

Model Number N/A

Device Problem Device Damaged Prior to Use (2284)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.Event occurred during a cadaver lab on campus; however the device location is now unknown.There are warnings in the package insert that state that this type of event can occur: under warnings: correct handling of instruments is extremely important.Most instruments are not intended to be modified, notched, bent, etc.As notches, scratches or other damage and/or wear in the instrument occurring during surgery may contribute to breakage or affect the performance of the instrument.This report is number 3 of 4 mdrs filed for the same event (reference 1825034-2014-04868 / 04871).

Event Description

Passer did not advance during a cadaver lab.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Review of the complaint history determined that no further action(s) is/are required.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.

• Brand Name: EZ PASS 30 DEGREE RIGHT
• Type of Device: PASSER
• Manufacturer (Section D): BIOMET SPORTS MEDICINE; 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: 6126048
• MDR Text Key: 61093464
• Report Number: 0001825034-2016-04870
• Device Sequence Number: 1
• Product Code: HWQ
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 904055
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1