MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; QUATTRO DYNACLIP STAPLE, 22X20X20

Catalog Number	3000-11-222020
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Revusion surgery - due to broken implant, non-union.
Additional Manufacturer Narrative
Additional reporting on this event will be provided as a supplemental report to this document as soon as it becomes available.
Additional Manufacturer Narrative
See h6 and h11 his complaint was opened to address the report of a dynaclip and dynaclip quattro staple revision removal surgery that occurred on (b)(6) 2025.The reported stated that two of the legs on the two-legged dynaclip staple broke midshaft and one of the dynaclip quattro legs had also broken off at the corner.These events resulted in a non-union at the nc joint.The product was not returned, nor were there any images provided by the representative; thus, a complete evaluation and investigation could not be completed.The dynaclip risk matrix was reviewed.The failure mode of the staple breaking post-operatively is recorded and accounted for.In the risk matrix, this failure mode is listed with the potential causes of failure as manufacturing error, improper dimensions, abnormal anatomy causes excessive strains on the staple, or a failed fusion.It is unknown if the surgical technique was adhered to as well as if the patient was compliant with the information provided, but there were no reported deviations.With the information provided, a definitive probable root cause remains unknown.The potential failure is ranked with a detection score of 2, device and patient severity of 3, and occurrence of 1.A historical search was conducted in the timeframe of (b)(6) 2024 to (b)(6) 2025 and results showed that this was the third occurrence of a complaint for this failure mode to the dynaclip family.Based on a sales volume of 3761 from (b)(6) 2024 to (b)(6) 2025, the occurrence level of remote is appropriate and over the year occurred at a (b)(4).Rate.The hazard is an anticipated risk within the risk analysis matrix and the current occurrences are within the anticipated threshold.Thus, this is not an indication of a systematic issue necessitating a capa investigation.The dynaclip risk analysis matrix was generated using the legacy medshape risk management sop occurrence level comparison is in alignment with that procedure.The hazard is an anticipated risk within the risk analysis matrix and the current occurrences are within the anticipated threshold.The probable root cause remains unknown.Thus, this is not an indication of a systematic issue necessitating a capa investigation.It will continue to be monitored.Therefore, no further action is needed.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: QUATTRO DYNACLIP STAPLE, 22X20X20
• 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: 22288619
• Report Number: 3007593722-2025-00012
• Device Sequence Number: 8922110
• Product Code: JDR
• UDI-Device Identifier: M9703000112220200
• UDI-Public: M9703000112220200
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D481243
• 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: 3000-11-222020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 06/18/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown