MAUDE Adverse Event Report: BIOMET SPORTS MEDICINE SLOTTED MAXCUTTER; ACCESSORIES, ARTHROSCOPIC

Model Number N/A

Device Problems Dull, Blunt (2407); Device Operates Differently Than Expected (2913)

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

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

No product or photos have been received, therefore the condition of the device is unknown.Review of device history records show the lot released with no recorded anomaly or deviation.This device is used for treatment.Current information is insufficient to permit a conclusion as to the cause of the event.The following could not be completed with the limited information provided: age/date of birth: ni, weight: ni, expiration date: na.

Event Description

It was reported that while trying to use the device during a procedure, the device was noted to be stiff and blunt, making the procedure more complicated than necessary.No further information provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Original aware date: nov 21, 2016.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: SLOTTED MAXCUTTER
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• 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: 6186314
• MDR Text Key: 62749419
• Report Number: 0001825034-2016-05158
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/31/2017

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: Physician
• Device Model Number: N/A
• Device Catalogue Number: 904808
• Device Lot Number: 448560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: 08/30/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2013
• 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