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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. RETROGRADE FEMORAL MODULAR HEX SCREWDRIVER ROD, FIXATION

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ZIMMER BIOMET, INC. RETROGRADE FEMORAL MODULAR HEX SCREWDRIVER ROD, FIXATION Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem Abrasion (1689)
Event Date 07/31/2020
Event Type  Injury  
Manufacturer Narrative
Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Concomitant medical devices: item number: 47-2494-240-11 , item name: retrograde nail, lot number: 61558422; item number: 47-2484-030-50 , item name: screw, lot number: 63799260 or 64377253; item number: unknown, item name: unknown jig assembly lot number: unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
 
Event Description
It was reported during an open reduction and internal fixation, the screwdriver was used within the patient to screw down several screws. Subsequently, the screwdriver fractured. This resulted in the surgeon's hand being cut. The surgeon left the surgery to cleanse the cut, but then returned to surgery once the bleeding stopped. Attempts have been made and no additional information is available at this time.
 
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Brand NameRETROGRADE FEMORAL MODULAR HEX SCREWDRIVER
Type of DeviceROD, 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 Key10477655
MDR Text Key205263992
Report Number0001822565-2020-02899
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101622
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number00249003580
Device Lot Number61628451
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 Received10/30/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/22/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 09/01/2020 Patient Sequence Number: 1
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