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U.S. Department of Health and Human Services

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

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ZIMMER BIOMET, INC. UNK LAG SCREW ROD, FIXATION Back to Search Results
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.
 
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Brand NameUNK LAG SCREW
Type of DeviceROD, FIXATION
Manufacturer (Section D)
ZIMMER BIOMET, INC.
56 e. bell drive
warsaw IN 46582
MDR Report Key8437838
MDR Text Key139454465
Report Number0001822565-2019-01223
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received03/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/27/2019
Is This a Reprocessed and Reused Single-Use Device? No

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