MAUDE Adverse Event Report: MEDSHAPE, INC. DYNACLIP BONE FIXATION SYSTEM, QUATTRO, 22MM X 16MM X 16MM; QUATTRO DYNACLIP STAPLE, 22X16X16

Catalog Number	3000-11-221616
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the staple was put over an evans titanium wedge to keep in place and the legs ended up breaking on the staple causing pain.
Additional Manufacturer Narrative
It was reported that the staple was put over an evans titanium wedge to keep in place and the legs ended up breaking on the staple causing pain.There were two similar complaints identified in the timeframe reviewed.One similar complaint was attributed to non-compliance and the other was attributed to design.The similar complaints do not aid in root cause determination as there was no reported non-compliance, and the damaged staple is a newer revision.There were no abnormalities noted in regards to dhr review.Dhr review confirmed the staple was released in 2023, post design update.Per the ifu, the device can break when subjected to increased loading associated with nonunion or delayed union.The surgical technique and ifu do not advice against implanting over existing hardware.The broken dynaclip quattro staple was not returned so full visual inspection and dimensional inspection did not occur.Simulated use testing did not occur.The reporter provided an x-ray of the broken dynaclip quattro staple prior to removal.The distal legs of the staple do not appear to be properly implanted into the bone, resulting in the proximal legs potentially taking all the loading and forces.Per sr.Clinical sales specialist sc, "the mode of failure to the staple was likely the positioning of the wedge.The anterior fragment likely subluxed dorsally causing movement to the wedge and staple.The wedge likely put a much higher level of stress on the legs with movement causing the break." as the explanted staple was not returned and the original implantation position remains unknown, bone or wedge movement can not be confirmed.Due to limited information provided, the root cause shall remain as unknown.

• Brand Name: DYNACLIP BONE FIXATION SYSTEM, QUATTRO, 22MM X 16MM X 16MM
• Common Device Name: QUATTRO DYNACLIP STAPLE, 22X16X16
• 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
• MDR Report Key: 20072568
• Report Number: 3007593722-2024-00008
• Device Sequence Number: 6414130
• Product Code: JDR
• UDI-Device Identifier: M9703000112216160
• UDI-Public: M9703000112216160
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: D481243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• 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): 08/26/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3000-11-221616
• Device Lot Number: 05876
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 08/26/2024
• 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 Age: 47 YR
• Patient Sex: Female