MAUDE Adverse Event Report: MEDSHAPE, INC. DYNACLIP DELTA; DELTA DYNACLIP STAPLE, 28X16X14X12

Catalog Number	3000-10-28161412
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
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
It was reported that and xray the patient had done in (b)(6) 2025 showed broken staple.The doctor does not intend to revise at this time as the patient has no pain or irritation.
Additional Manufacturer Narrative
This complaint was generated in response to a report of a dynaclip delta case initial executed in march.The reporter stated it was the surgeon's first dynaclip delta case but the case was successful and the first post-operative x-rays in may showed no issues.He was then seen in august for a scheduled check in and x-rays revealed the staple had broke along the top of the staple.The patient was not diabetic and neuropathy was not a factor.The patient reports no pain and is generally healthy.Due to this, the staple remains in the patient.The representative attached 4 x-rays: 2 from the may visit showing no breakage, and 2 from august visit showing the broken staple.The x-rays were evaluated and investigated by the dynaclip clinical expert and no factors were identified based on the visuals and information provided that would have contributed or have caused the break.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 or this failure mode of breaking post-operatively to the dynaclip family.Based on a sales volume of 3767 in the above-mentioned timeframe, 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.

• Brand Name: DYNACLIP DELTA
• Common Device Name: DELTA DYNACLIP STAPLE, 28X16X14X12
• 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: 23022869
• Report Number: 3007593722-2025-00016
• Device Sequence Number: 21287196
• Product Code: JDR
• UDI-Device Identifier: M970300010281614120
• UDI-Public: M970300010281614120
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220812
• 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): 10/23/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3000-10-28161412
• Device Lot Number: 20012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/23/2025
• 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; Other
• Patient Sex: Unknown