MAUDE Adverse Event Report: MEDSHAPE, INC. DYNANAIL; DELTA DYNACLIP STAPLE, 24X16X14X12

Catalog Number	3000-10-24161412
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported staple wouldn't deploy off the handle in case.Bone fractured trying to implant.
Additional Manufacturer Narrative
Staple wouldn't deploy off the handle in case.Bone fractured trying to implant.Was able to use graft and upsize the implant and it worked fine.This complaint was opened up in response to a report of a dynaclip delta staple that had difficulty deploying.Reportedly, the staple had difficulty removing from the handle and consequently, bone fractured trying to implant.The surgeon was able to use graft and upsize the implant and the surgery was able to be completed successfully with no significant delay.Previously, car-00859 was initiated to investigate and remedy the current issue of the dyncalip staples having difficulty deploying.Hhe-00071 was also opened to investigate field inventory.The main change implemented from the capa was removing the mandatory use of the arbor press in manufacturing.This was implemented 5/20/2025 and monitored for effectiveness through 01/26/2026, in which, the changes were deemed successful and the capa was closed.The dynaclip risk matrix risk-fa005-001 rev a.(ed-50260 risk management document-design, dynaclip, rev 10), was reviewed.In the risk matrix, 'difficulty releasing staple after successful insertion was accounted for, the risk was ranked a score of detection 3, severity 3 and occurrence 1.The potential effects of the failure occurrence are the need to replace the staple, a procedural delay and surgeon hassle.This risk severity was rated 3 per legacy qs-7.1-08, risk management because difficulty disengaging the inserter from the staple has the worst-case potential of causing patient harm through loss of function or revision surgery.This is the first occurrence of this defect to the product family since the implementation verification to be 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 but will continued to be monitored.

• Brand Name: DYNANAIL
• Common Device Name: DELTA DYNACLIP STAPLE, 24X16X14X12
• 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: 25342859
• Report Number: 3007593722-2026-00004
• Device Sequence Number: 5239182
• Product Code: JDR
• UDI-Device Identifier: M970300010241614120
• UDI-Public: M970300010241614120
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K220812
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 05/30/2026

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: 3000-10-24161412
• Device Lot Number: 32269
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/31/2026
• 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: Female