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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. FLUSH IMPING 1ST SCREW SCREW, FIXATION
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ZIMMER BIOMET, INC. FLUSH IMPING 1ST SCREW SCREW, FIXATION Back to Search Results
Catalog Number 181701001
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Concomitant medical products: 1817-09-221 universal hum nail 9x220mm m16577, 1818-48-046 4. 8mm canc screw sterile 46mm m16366a, 1818-48-050 4. 8mm canc screw sterile 50mm m06468f, 8050-45-034 4. 5 solid cort ft x 34mm m09628b, 8050-45-036 4. 5 solid cort ft x 36mm m12770a, 8050-45-038 4. 5 solid cort ft x 38mm m04323f, 8050-45-040 4. 5 solid cort ft x 40mm m03283f. Report source: (b)(6). 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 report will be submitted.
 
Event Description
It was reported that the implant loosened after implantation. A revision procedure has not occurred at this time.
 
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Brand NameFLUSH IMPING 1ST SCREW
Type of DeviceSCREW, 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 Key11320907
MDR Text Key231593370
Report Number0001825034-2021-00446
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K033878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number181701001
Device Lot NumberM17352A
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 Received06/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/17/2018
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: 02/12/2021 Patient Sequence Number: 1
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