MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL BIT FAST 2.0MM; BIT, DRILL

Model Number N/A

Device Problem Corroded (1131)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Concomitant medical devices: 231218012, alps elbow 1.3 mm square screwdriver, 155245; fdb20, dvr classic drill bit fast 2.0mm, zb160213; 214288007, misc trauma insert multi direct 2.0mm, 453681; 829960040, alps foot 2.5 screw/imp module, unknown.Events occurred in (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation.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: 0001825034-2017-11075, 0001825034-2017-11077, 0001825034 - 2017-11078, 0001825034-2017-11079.

Event Description

It was reported that the instruments were rusty and stained.No adverse events have been reported as a result of the malfunction.Attempts have been made and additional information on the reported event is unavailable.

Manufacturer Narrative

This follow-up report is being submitted to relay corrected information.Upon reassessment of the reported event, it was determined to be not reportable as this component did not cause serious injury.

• Brand Name: DRILL BIT FAST 2.0MM
• 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: 7129500
• MDR Text Key: 95961338
• Report Number: 0001825034-2017-11076
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• 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: FDB20
• Device Lot Number: ZB160408
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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