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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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ZIMMER BIOMET, INC. 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number N/A
Device Problems Unstable (1667); Migration (4003)
Patient Problem Joint Laxity (4526)
Event Date 08/22/2013
Event Type  Injury  
Event Description
It was reported patient was revised approximately 10 days post implantation due to instability under mobilization ending in a secondary dislocation of the nail. Attempts have been made and additional information on the reported event is unavailable at this time.
 
Manufacturer Narrative
(b)(4). Concomitant medical products: 47249532011 62266723 tibial nail - yellow 11 mm diameter 32 cm length use red proximal and red distal screws; 47248403050 62321950 5. 0 mm diameter cortical screw; 47248403550 62330386 5. 0 mm diameter cortical screw; 47248403550 62340928 5. 0 mm diameter cortical screw; 47248403050 62321950 5. 0 mm diameter cortical screw; 47248405250 62214118 5. 0 mm diameter cortical screw; 47248403550 62321879 5. 0 mm diameter cortical screw. Report source: foreign country: (b)(6). Customer has indicated that the product will not be returned to zimmer biomet for investigation, due to the location of the device is unknown. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2021-02531, 0001822565-2021-03070, 0001822565-2021-03542, 0001822565-2021-03543, 0001822565-2021-03544, 0001822565-2021-03547.
 
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Brand Name5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key12968181
MDR Text Key281991680
Report Number0001822565-2021-03546
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 01/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47248405250
Device Lot Number62214118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/11/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/12/2012
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

Patient Treatment Data
Date Received: 12/09/2021 Patient Sequence Number: 1
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