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

Catalog Number 212000002

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Foreign source - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-0075, 0001825034-2019-00749, 0001825034-2019-00832, 0001825034-2019-00834, 0001825034-2019-00836, 0001825034-2019-00838, 0001825034-2019-00841, 0001825034-2019-00842, 0001825034-2019-00845, 0001825034-2019-00849, 0001825034-2019-00851, 0001825034-2019-00852, 0001825034-2019-00853, 0001825034-2019-00854, 0001825034-2019-00856, 0001825034-2019-00858, 0001825034-2019-00859, 0001825034-2019-00860.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that during incoming inspection, a weak seal and open seal issue on the sterile package was identified.There was no patient involvement.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.Visual inspection of the returned products identified that all 18 parts have defective seals.Device history record was reviewed and no discrepancies were found.The root cause of the reported event is likely to be due to design deficiency.Corrective action has been initiated due to the reported event through the capa process.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

No further event information available at the time of this report.

• Brand Name: DVR SCREW DRIVER STERILE
• Type of Device: INSTRUMENT, TRAUMA
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8373188
• MDR Text Key: 137265331
• Report Number: 0001825034-2019-00850
• 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
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

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: Health Professional
• Device Expiration Date: 10/02/2020
• Device Catalogue Number: 212000002
• Device Lot Number: 235473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1946-2019
• Patient Sequence Number: 1