MAUDE Adverse Event Report: MEDSHAPE, INC. ACTIVE ADAPTIVE; DYNACLIP STAPLE, 10X10X10MM

Catalog Number	3000-00-101010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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
Complaint - dynaclip would not release from inserter handle.Surgeon had to discard and use a 2nd staple, leading to a significant delay in surgery.
Additional Manufacturer Narrative
This is the first complaint opened for this dynaclip product family (3000-00-101010).This failure mode is accounted for in the risk management document risk-fa005-0001 (d-50260 risk management document-design, dynaclip, rev 10.).In the matrix under the inserter section, "difficulty releasing staple after successful insertion" is listed as a potential failure; it is ranked with a detection level 3, patient severity 3 and occurrence 1.Potential causes of failure for this risk include a manufacturing error, improper dimensions or material selection or poor ergonomics.It should be noted that car-00859 was opened for complaints relating to a similar issue with the dynaclip delta and quattro staple deployment from the inserter (parent case: (b)(4)), in which, the investigation stated that a probable cause for the issue was the arbor press.Prior to the capa, the arbor press was included in 2000.1726 dynaclip staple loading work instructions as an optional step.If the proper technique on the loading fixture is used, the arbor press is not needed.From the capa, the dynaclip work instructions were updated and no longer allow for the use of the arbor press, this includes all dynaclips.It cannot be confirmed for this specific scenario if the arbor press was used since the lot this staple came from was manufactured in february 2022 when the use of the arbor press was still permitted.However, in the case that the press caused this issue, it is no longer permitted in manufacturing.This is an isolated case, and the first occurrence 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.
Additional Manufacturer Narrative
This is the first complaint opened for this dynaclip product family (3000-00-101010).This failure mode is accounted for in the risk management document risk-fa005-0001 (d-50260 risk management document-design, dynaclip, rev 10.).In the matrix under the inserter section, "difficulty releasing staple after successful insertion" is listed as a potential failure; it is ranked with a detection level 3, patient severity 3 and occurrence 1.Potential causes of failure for this risk include a manufacturing error, improper dimensions or material selection or poor ergonomics.It should be noted that car-00859 was opened for complaints relating to a similar issue with the dynaclip delta and quattro staple deployment from the inserter (parent case: (b)(4), in which, the investigation stated that a probable cause for the issue was the arbor press.Prior to the capa, the arbor press was included in 2000.1726 dynaclip staple loading work instructions as an optional step.If the proper technique on the loading fixture is used, the arbor press is not needed.From the capa, the dynaclip work instructions were updated and no longer allow for the use of the arbor press, this includes all dynaclips.It cannot be confirmed for this specific scenario if the arbor press was used since the lot this staple came from was manufactured in february 2022 when the use of the arbor press was still permitted.However, in the case that the press caused this issue, it is no longer permitted in manufacturing.This is an isolated case, and the first occurrence 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.

• Brand Name: ACTIVE ADAPTIVE
• Common Device Name: DYNACLIP STAPLE, 10X10X10MM
• 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: 21915076
• Report Number: 3007593722-2025-00004
• Device Sequence Number: 7109353
• Product Code: JDR
• UDI-Device Identifier: M9703000001010100
• UDI-Public: M9703000001010100
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: D334257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 07/23/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 3000-00-101010
• Device Lot Number: 05165
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 07/08/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 53 YR
• Patient Sex: Female