MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS LAPIPLASTY SYSTEM 1 - ANATOMIC BIPLANAR IMPLANTS; PLATE

Catalog Number	SK12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	09/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery, all hardware was removed and replaced in a revision surgery on (b)(6) 2024 due to non-union and a broken plate that was discovered via 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's height was 6'5" and weight was 260 pounds.No devices were returned for evaluation.Device-specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for possible kits utilized in surgery were reviewed and no non-conformances or issues during the manufacture or release of the products were identified to date 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 broken plate was likely subjected to excessive bending stresses which resulted in the breakage and contributed to the non-union.The company will supplement the mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery, all hardware was removed and replaced in a revision surgery on (b)(6) 2024 due to non-union and a broken plate that was discovered via radiographic image from a post-op follow-up.No other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
Updated fields: d9: is this device available for evaluation? yes, date returned to manufacturer: 10-28-2024.G3: date received by manufacturer: 10-28-2024.G6: type of report: 30-day follow-up.H2: if follow-up, what type: additional information.H3: device evaluated by manufacturer: yes.H6: type of investigation: 10.Investigation findings: 3243.H11: it was reported that after an initial bunion surgery, all hardware was removed and replaced in a revision surgery on (b)(6) 2024 due to non-union and a broken plate that was discovered via 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's height was 6'5" and weight was 260 pounds.The hardware was returned for evaluation.Analysis of the returned hardware confirms the reported issue of a broken plate.Device-specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformance's for possible kits utilized in surgery were reviewed and no non-conformance's or issues during the manufacture or release of the products were identified to date 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 broken plate was likely subjected to excessive bending stresses which resulted in the breakage and contributed to the non-union.The company will supplement the mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY SYSTEM 1 - ANATOMIC BIPLANAR IMPLANTS
• Common Device Name: PLATE
• 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: 20500336
• Report Number: 3011623994-2024-00190
• Device Sequence Number: 7471924
• Product Code: HRS
• UDI-Device Identifier: 00810111221337
• UDI-Public: (01)00810111221337
• 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 Explanted 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,Followup
• Report Date (Section B): 11/19/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SK12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/21/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 118 KG