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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PRX HUM HI PLT RT 3H 80MM FASTENER, FIXATION

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ZIMMER BIOMET, INC. PRX HUM HI PLT RT 3H 80MM FASTENER, FIXATION Back to Search Results
Model Number N/A
Device Problem Difficult to Insert (1316)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/01/2021
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Concomitant medical products: catalog #: 816140032, 4. 0mm canc lock screw 32mm, lot # unknown. The device will not be returned for analysis, as the device remains implanted; however, an investigation of the reported event is in progress. Once the investigation is completed, a supplemental medwatch 3500a will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-00867.

 
Event Description

It was reported that the surgeon has a locking screw head passed through the plate. Screw was removed and replaced with multi-directional screw and tightened with torque limiting screwdriver until click indicated proper torque was reached. Screw hole in plate was the most proximal anterior hole in the plate. Attempts have been made and there is no further information at this time.

 
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Brand NamePRX HUM HI PLT RT 3H 80MM
Type of DeviceFASTENER, FIXATION
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 Key11565644
MDR Text Key245464514
Report Number0001825034-2021-00868
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143697
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/17/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue Number110030400
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received06/14/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

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