MAUDE Adverse Event Report: ZIMMER BIOMET, INC. ALPS SMALL FRAGMENT DRILL BIT; BIT, DRILL

Catalog Number 829029070

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report was previously submitted incorrectly under report number: 0001822565 -2017-06510.Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned packaging confirmed that the drill bit is missing from the package as reported.Device history record was reviewed and no discrepancies were found.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.

Event Description

It was reported that a drill bit was missing from the package.No adverse events have been reported as a result of the malfunction.

• Brand Name: ALPS SMALL FRAGMENT DRILL BIT
• Type of Device: BIT, DRILL
• 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: 7348083
• MDR Text Key: 102735714
• Report Number: 0001825034-2018-02019
• 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
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 829029070
• Device Lot Number: ZB161208
• Other Device ID Number: (01) 00887868050015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1