MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR SCREW DRIVER STERILE; TRAUMA, INSTRUMENT

Model Number N/A

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Report source foreign (b)(6).Udi# (b)(4).Complaint sample was evaluated and the reported event was confirmed.Inspection of the returned device revealed that the reported device has a defective seal.Device history record was reviewed and no discrepancies were found.The root cause of the event is attributed to the design of the device.Corrective / preventive actions related to the reported event have been previously addressed.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 during incoming inspection, the seal on the sterile package was found weak.There was no patient involvement.

• Brand Name: DVR SCREW DRIVER STERILE
• Type of Device: TRAUMA, INSTRUMENT
• 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: 10042899
• MDR Text Key: 190512179
• Report Number: 0001825034-2019-03415
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/05/2019

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: Other
• Device Expiration Date: 10/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 212000002
• Device Lot Number: 235472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1946-2019
• Patient Sequence Number: 1