MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; ECLIPSE, 7MM X 20MM

Catalog Number	1500-00-0720
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
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
Instrument breakage - fragmented pieces left in patient.
Additional Manufacturer Narrative
This case was opened for a report of a tip of an eclipse implant inserter that broke off during surgery.The report states that the threaded tip of an inserter broke off when the anchor (7mm x 2mm) was deployed from the eclipse disposable gun and remains in the patient.An image was provided of the broken inserter by the sales representative.The product was not returned, and no further information was provided so a complete evaluation and investigation could not be conducted.In the eclipse design risk matrix document, risk-fa006-001 (medshape ed-50142-06) rev a.The potential failure of the delivery system (deployment gun) breaking in implant on insertion is recorded and accounted for.The potential cause for this failure is if the surgeon inserts the insert off angle, specifically, an angle not in line with respect to the bone tunnel axis.This potential failure is ranked with a detection of 1, a severity of 2 (device severity of 3) and an occurrence of 1.A historical search from 03/01/2024 to 12/11/2024 was conducted and results showed that this was the first occurrence of this failure mode for this product family.This is an isolated case, and the first occurrence reported.The hazard is an anticipated risk within the risk analysis matrix and a single occurrence is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.This is an isolated case, and the first occurrence reported.The hazard is an anticipated risk within the risk analysis matrix and a single occurrence is not an indication of a systematic issue.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: ECLIPSE, 7MM X 20MM
• 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: 21098319
• Report Number: 3007593722-2024-00019
• Device Sequence Number: 8935215
• Product Code: GAT
• UDI-Device Identifier: M97015000007200
• UDI-Public: M97015000007200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D201781
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/01/2025

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
• Device Catalogue Number: 1500-00-0720
• Device Lot Number: 04782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown