MAUDE Adverse Event Report: BIOMET ORTHOPEDICS S S BIT 5X1/8; BIT, DRILL

Catalog Number 180118000

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2017

Event Type  malfunction  

Manufacturer Narrative

Cmp-(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports:0001825034 - 2017 - 02464 , 0001825034 - 2017 - 02465, 0001825034 - 2017 - 02466, 0001825034 - 2017 - 02467 , 0001825034 - 2017 - 02468, 0001825034 - 2017 - 02469 , 0001825034 - 2017 - 02470, 0001825034 - 2017 - 02471.

Event Description

It was reported nine out of ten packages of the order arrived empty.No adverse events have been reported as a result of the malfunction, as there was no patient involvement.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The following sections were updated: manufacture date - sep 21, 2016.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.

Manufacturer Narrative

(b)(4).Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned packaging confirmed that the drill bits are missing from the packages as reported.The root cause of the reported event is attributed to manufacturing deficiency.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: S S BIT 5X1/8
• Type of Device: BIT, DRILL
• 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: 6480259
• MDR Text Key: 72511162
• Report Number: 0001825034-2017-02462
• Device Sequence Number: 1
• Product Code: HTW
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Catalogue Number: 180118000
• Device Lot Number: ZB160801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1