MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; IMPLANT FAILURE

Catalog Number	1200-01-1226
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Event or Problem Description
Revision surgery - due to implant failure.
Additional Manufacturer Narrative
See h6, and h11.This complaint was opened from a report of a dynanail ttc revision surgery in which the implant failed.The parts were returned to be evaluated and investigated by engineering.Based on the evaluation and investigation of the returned samples, there was no abnormalities, breakages or defects noted on the device that would have led to needing a removal surgery.The information provided on the case from the reporter also made no note to the reason of needing the removal surgery.For these reasons, the probable root cause for the implant needing to be removed in unknown.The dynanail design risk matric was reviewed and the potential effect of a revision surgery is documented and accounted for under two-line items.The failure mode of a screw backing out of a bone is ranked with a detection score of 2, patient severity of 3 (device severity of 3) and occurrence of 1.The applicable potential cause is documented as insufficient friction of screw threads to bone.Additionally, another potential failure that could result in revision surgery is end caps becoming loose after insertion.This potential failure is ranked with a detection score of 2, patient severity of 2 (device severity of 2) and occurrence of 1.Potential causes of failure include insufficient torque during insertion, low friction between endcap threads and sliding element.Other potential failures that could drive the need of a revision surgery for removal include if the patient has an infection, if they are requiring a new surgery with different hardware or if there was a non-union.Since the probable root cause is unknown, the specific reason for failure is undetermined.A historical search in the time frame of 04/04/2024 to 04/03/2025 was conducted and revealed that there were 10 cases of dynanail ttc revision surgery executed to remove hardware for various reasons including this complaint.Breakdown of the ten (10) complaints are as follows: two (2) non-compliance, two (2) infection, three (3) unknown, one (1) pain, one (1) nail break, and one (1) instrument related.The hazard is an anticipated risk within the risk analysis matrix, and a without a probable root cause this is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: IMPLANT FAILURE
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside dr. nw; suite 440; atlanta GA 30318
• Manufacturer (Section G): MEDSHAPE, INC.; 1575 northside dr. nw; suite 440; atlanta GA 30318
• Manufacturer Contact: stacey bonnell ; 1575 northside dr nw; suite 440; atlanta, GA 30318 ; 4847879764
• MDR Report Key: 21915078
• Report Number: 3007593722-2025-00006
• Device Sequence Number: 7238279
• Product Code: HSB
• UDI-Device Identifier: M97012000112260
• UDI-Public: M97012000112260
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: D155711
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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): 09/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1200-01-1226
• Device Lot Number: D0101E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 1200-02-5030 LOT: C6236I.; 1200-02-5045 LOT: C6224B.; 1200-03-5110 LOT: 03108R.; 1200-04-0000 LOT: 17906.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male