MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC LAPIPLASTY LESSER TMT FIXATION PACK; PLATE

Model Number	SK28
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2023, a broken plate on the 3rd metatarsal was discovered during a follow-up visit via radiographic imaging, approximately five and half weeks post-surgery.Additional information indicates the surgeon wants to let the bones fuse and reevaluate the patient's needs at a later date.No revision/removal surgery has been planned or scheduled at this time.It's possible that the patient may have been distributing her weight toward the outside of her foot (toward the 3rd metatarsal) to prevent too much weight from being loaded onto her 1st metatarsal.The device was not returned to the manufacturer for evaluation as it currently remains implanted in the patient.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.A number of factors could have contributed to what was reported and although the most likely cause cannot be determined based on the available information, the device was likely subjected to excessive bending stresses which resulted in its breakage.Although there has been no impact or injury reported and this malfunction has not resulted in a revision surgery to date, there have been similar events where this malfunction has resulted in a revision surgery.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023, a broken plate on the 3rd metatarsal was discovered during a follow-up visit via radiographic imaging, approximately five and half weeks post-surgery.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.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2023 hardware (1 plate and 4 screws) was removed due to a broken plate.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 Manufacturer Narrative
Updated fields: b1 adverse event & product problem b5 describe event of problem: it was reported that after an initial bunion surgery on 04-14-2023 hardware (1 plate and 4 screws) was removed due to a broken plate.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.D4 lot number: 300062001; expiration date: 11/18/2024 d9 date returned to manufacturer: 09/01/2023 g3 date received by manufacturer: 09/01/2023 g6 type of report: 30-day, follow-up h2 if follow-up, what type: additional information, device evaluation h3 device evaluated by manufacturer- yes; evaluation summary attached h4 device manufacturer date: 11/18/2021 h6 adverse event problem health effect- impact code: 4627 device explantation type of investigation: 10 testing of actual/ suspected device investigation findings: 3243 stress problem identified investigation conclusions: 4315 cause not established.H10 additional narrative/ data: it was reported that after an initial bunion surgery on 04-14-2023 hardware (1 plate and 4 screws) was removed due to a broken plate.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.The device was returned for evaluation, analysis of the returned device confirms the reported issue of a plate breaking between the center holes.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.A number of factors could have contributed to what was reported and although the most likely cause cannot be determined based on the available information, the device was likely subjected to excessive bending stresses which resulted in its breakage.The company will supplement this mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY LESSER TMT FIXATION PACK
• Common Device Name: PLATE
• 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 32081 ; 9043735940
• MDR Report Key: 17181596
• Report Number: 3011623994-2023-00153
• Device Sequence Number: 6542401
• Product Code: HRS
• UDI-Device Identifier: 00853114006204
• UDI-Public: 00853114006204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K220136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/18/2024
• Device Model Number: SK28
• Device Lot Number: 300062001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 09/01/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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 Age: 43 YR
• Patient Sex: Female