MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY SPEEDPLATE QUAD 28X17X14MM ANATOMIC COMPRESSION IMPLANT; STAPLE

Model Number	SK53
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2024, two backed out speedplates were discovered via a radiographic image from a post-op follow-up.No other patient outcomes were reported as a result of this event.Although there has been no injury reported and no information has been received indicating this malfunction has resulted in a revision surgery to date, there have been similar events where this malfunction has resulted in a revision surgery.Therefore, an mdr will be filed to ensure full compliance with 21 cfr part 803.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2024, two backed out speedplates were discovered via a radiographic image from a post-op follow-up.No other patient outcomes were reported as a result of this event.Additional information indicates the patient is also being treated for cellulitis and has experienced a near-complete loss of correction.The surgeon noted the patient walks on the foot without a boot, has not used their scooter, and has been weight-bearing before the surgeon allowed it.No devices were returned for evaluation as the hardware remains implanted.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.Although a number of factors could have contributed to what was reported, additional information indicates it is likely that patient non-compliance could have contributed to what the patient experienced.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in 3011623994-2024-00237.

• Brand Name: LAPIPLASTY SPEEDPLATE QUAD 28X17X14MM ANATOMIC COMPRESSION IMPLANT
• Common Device Name: STAPLE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 20815525
• Report Number: 3011623994-2024-00236
• Device Sequence Number: 9302195
• Product Code: JDR
• UDI-Device Identifier: 00810111222396
• UDI-Public: (01)00810111222396
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K232387
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK53
• Device Lot Number: 300522901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 12/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male