MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DRILL BIT 4.0MM STERILE; BIT, DRILL

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2014

Event Type  malfunction  

Manufacturer Narrative

The product was returned for evaluation and the complaint was confirmed.Per engineer's investigation, "the label has a 4 that appears as a 1".Internal actions were taken to address this issue.Review of the dhr found units were released for distribution with no deviation or anomaly.Review of complaint history found no additional issues or trends.The suspected root cause of this label misprint is a small wrinkle in the printing ribbon making this an incident isolated to this label.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation."product is not labeled, or is mislabeled/incorrect information on the label." following review, no new risks were identified.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.Zimmer biomet complaint (b)(4).

Event Description

It was reported that the label on outside of box states "drill bit 1.0" instead of "drill bit 4.0mm".This item has been unopened and not used during a procedure.No patient impact.No further information has been provided.

• Brand Name: DRILL BIT 4.0MM STERILE
• 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: 6915460
• MDR Text Key: 88245877
• Report Number: 0001825034-2017-07902
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 212957014
• Device Lot Number: 930000
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/22/2014
• 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