MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL HELIX; DYNAFUSE, HEADLESS 70MM, PACKAGED

Catalog Number	3200-01-7070
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint was generated in response to the report of a dynanail helix headless 70mm screw that broke intraoperatively.The implant was being removed in a revision surgery, and the screw head broke off the implant.No fragments were left in the patient.The original implant date was 9b)(6) 2023.The reporter noted the bone quality as sclerotic.The broken sample was discarded at the facility and not returned so a complete evaluation and investigation could not be completed.An image was provided of the sample.Engineering and the product manager visually inspected the image and confirmed its breakage.The dynanail helix risk matrix was reviewed.In it, the failure mode of implant breaking intraoperatively is documented and accounted for.The potential cause of failure are listed as manufacturing error (implant out of specification), mishandling or misuse by clinician, or inadequate design.The hazard is ranked with a detection of 2, a patient severity of 2, a device severity of 3 and an occurrence of 1.The dynanail helix surgical technical guide, was also reviewed and a possible root cause of the implant breaking.The proper technique for removal is using the blue-handle ratchet driver, if other tools or techniques were used it could cause the device to break.It is unknown if the surgical technique was adhered to with the information provided, but there were no reported deviations.A definitive probable root cause remains unknown.In the risk matrix, the failure mode is ranked with a detection of 3, severity of 3 and occurrence of 1.A historical search from the time frame of (b)(6) 2024 to (b)(6) 2025, showed that this was the second occurrence of this product family failure mode of breaking post-operatively.The dynanail helix risk analysis matrix referenced above, was generated using the legacy medshape risk management sop.Sales volume at this timeframe of 2062 indicate that this hazard is occurring at a.097% occurrence rate, this is aligned with the occurrence threshold set by the procedures and is not an indication of a systematic issue necessitating a capa investigation.Therefore, no further action is needed.
Event or Problem Description
Revision surgery - due to unknown reason.

• Brand Name: DYNANAIL HELIX
• Common Device Name: DYNAFUSE, HEADLESS 70MM, PACKAGED
• 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: 23824371
• Report Number: 3007593722-2025-00022
• Device Sequence Number: 20081864
• Product Code: HWC
• UDI-Device Identifier: M97032000170700
• UDI-Public: M97032000170700
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K203595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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: 3200-01-7070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/16/2025
• 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: Required Intervention
• Patient Sex: Unknown