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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: . 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD SCREW, FIXATION

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. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD SCREW, FIXATION Back to Search Results
Model Number 47-2484-040-50
Device Problem Migration (4003)
Patient Problems Bone Fracture(s) (1870); Pain (1994); Non-union Bone Fracture (2369)
Event Date 09/30/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). Report source: foreign: (b)(6). Concomitant products: cmn femoral nail, ccd 130â°, right, 㸠11. 5 mm, 21. 5 cm cat: 47249321211 lot: 3049030; znnâ¿¢, cmn lag screw, 㸠10. 5 mm, 110 mm including set screw cat: 47248511010 lot: 3042384. It is unknown if product will be returning to zimmer biomet and the investigation is in process. Once the investigation has been completed, a follow-up report will be submitted. Product not returned.
 
Event Description
It was reported that the patient underwent a right side hip nail insertion due to subtrochanteric bone fracture. It was discovered that the nail had migrated. The patient reported pain and femoral nonunion. There was no reported patient fall or false movement. The patient underwent a revision procedure to place a gtr hook plate and cerclage cable with a femoral allograft. Attempts have been made and additional information on the reported event is unavailable.
 
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Brand Name5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
Type of DeviceSCREW, FIXATION
Manufacturer (Section D)
.
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 Key13618189
MDR Text Key286232963
Report Number0001825034-2022-00403
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024094062
UDI-Public(01)00889024094062(17)300228(10)64689212
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K082770
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number47-2484-040-50
Device Catalogue Number47248404050
Device Lot Number64689212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/28/2022 Patient Sequence Number: 1
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