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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bone Fracture(s) (1870); Impaired Healing (2378)
Event Date 06/12/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4), concomitant products: 47249432011 62745903 retrograde femoral nail - purple 11. 5 mm diameterï ½ 32 cm length use red proximal screws and black distal fixed angle screws; 47248404560 62858594 6. 0 mm diameter cancellous screw ï ½ black ï ½ fixed angle 3. 5 mm hex head 45 mm length; 47248405060 62836167 6. 0 mm diameter cancellous screw - black fixed angle 3. 5 mm hex head; 47248404560 62858594 6. 0 mm diameter cancellous screw ï ½ black ï ½ fixed angle 3. 5 mm hex head 45 mm length; 47248403250 62924118 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head; 47248403250 62944830 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head; 47248405060 62743904 6. 0 mm diameter cancellous screw - black fixed angle 3. 5 mm hex head; 47248307060 61238422 6. 0 mm diameter cancellous screw - black partially threaded 3. 5 mm hex head. 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 - 02726, 0001822565 - 2021 - 03548, 0001822565 - 2021 - 03551, 0001822565 - 2021 - 03552, 0001822565 - 2021 - 03554, 0001822565 - 2021 - 03555, 0001822565 - 2021 - 03556.
 
Event Description
It was reported patient was revised due to bone fracture and wound healing defect approximately one month post implantation. It was reported patient experienced wound healing defect of the right knee with exposed osteosynthesis material. The patient underwent wound débridement, necrectomy, lavagae, vac installation. Four days later, debridement, lavage, vac change, then another four days later, defect coverage using free microvascular anastomosed latissimus dorsi flap, split skin graft and positioning fixator. One month later, tangential wound debridement and repeat split skin grafting. Attempts have been made and additional information on the reported event is unavailable at this time.
 
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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 Key12969167
MDR Text Key281997290
Report Number0001822565-2021-03553
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 01/14/2022
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? No
Device Operator
Device Model NumberN/A
Device Catalogue Number47248403250
Device Lot Number62924118
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2015
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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