MAUDE Adverse Event Report: ZIMMER BIOMET, INC. UNK LAG SCREW; ROD, FIXATION

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product not returned.

Event Description

It was reported that a znn lag screw snapped off the t-hand during insertion, making it impossible to re-attach.Used other means to get the lag screw back out again.No further information is available at this time.

Manufacturer Narrative

Upon receipt of additional information, it has been determined that the device needs to be reported under manufacturing site: 9613350.A new medwatch will be created.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

Upon receipt of additional information, it was determined this product should not have been reported under this mfr number.This report should be voided and a corrected report will be filed under mfr number 9613350.

Event Description

No additional event information is available at the time of this report.

Manufacturer Narrative

Report source: europe: uk.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.

• Brand Name: UNK LAG SCREW
• Type of Device: ROD, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• MDR Report Key: 8437838
• MDR Text Key: 139454465
• Report Number: 0001822565-2019-01223
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/20/2019
• Supplement Dates Manufacturer Received: 10/25/2019; 11/27/2019
• Supplement Dates FDA Received: 10/29/2019; 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1