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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC TMC SPEEDPLATE ANATOMIC; STAPLE

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TREACE MEDICAL CONCEPTS, INC TMC SPEEDPLATE ANATOMIC; STAPLE Back to Search Results
Model Number SK50
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Post Operative Wound Infection (2446)
Event Date 12/21/2023
Event Type  Injury  
Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to an incision infection.The surgeon treated the infection with an i&d.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.Additional information from the surgeon indicates the patient was non-compliant and kept removing his bandages.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, per feedback from the surgeon, it is likely that patient non-compliance could have contributed to what the patient experienced.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in 3011623994-2024-00023.
 
Event Description
It was reported that after an initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to an incision infection.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.
 
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Brand Name
TMC SPEEDPLATE ANATOMIC
Type of Device
STAPLE
Manufacturer (Section D)
TREACE MEDICAL CONCEPTS, INC
100 palmetto park place
ponte vedra FL 32081
Manufacturer (Section G)
TREACE MEDICAL CONCEPTS, INC
100 palmetto park place
ponte vedra FL 32081
Manufacturer Contact
renae ginter
100 palmetto park place
ponte vedra, FL 
9043735940
MDR Report Key18548439
MDR Text Key333315209
Report Number3011623994-2024-00022
Device Sequence Number1
Product Code JDR
UDI-Device Identifier00810111221788
UDI-Public00810111221788
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K232387
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberSK50
Device Lot Number300479236
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/21/2023
Initial Date FDA Received01/19/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/06/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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