MAUDE Adverse Event Report: MEDSHAPE, INC. DYNACLIP 2-LEG STAPLE; STAPLE, FIXATION, BONE

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Implant Pain (4561)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

On (b)(6), customer notified medshape of 1 broken dynaclip 2-leg staple that required removal from the patient due to reported pain.The original surgery was completed on this patient on (b)(6) 2021 and the staple functioned successfully to fuse the impacted bones.All additional information for exact part number, size and lot number of the staple was unavailable at the time of the report.Remaining specifics of staple implant, case information, patient notes, operative notes, and information to determine conclusive cause is unknown at this time and multiple requests have been made to obtain information needed for investigation.The device failure, which resulted in patient pain and removal, fits the category requiring a 30-day mdr to report per qs-8.2.1.3, sop, medical device reporting.In response to this event, qsf-8.2.1.2, health risk assessment form has been completed.Based on review of images of broken staples, a potential failure mode and root cause have been identified.Given the potential root cause (still to be confirmed pending receipt of additional information), health risk and failure mode analysis in qsf-8.2.1.2 have identified that the likelihood of this same manner of staple breakage occurring in the field is extremely unlikely, coupled with an extremely high success rate of these staples, no field action or market removal is necessary for this complaint.A supplemental mdr report will be filed for complaint 24-01-008 when all necessary information has been obtained and the complaint investigation has been completed.

Event Description

On (b)(6), customer notified medshape of 1 broken dynaclip 2-leg staple that required removal from the patient due to reported pain.The original surgery was completed on this patient in (b)(6) 2021 and the staple functioned successfully to fuse the impacted bones.All additional information for exact part number, size and lot number of the staple was unavailable at the time of the report.

Manufacturer Narrative

In conclusion, this investigation determined that the root cause of the staple breakage was that the rev.01 design of ed-10697.[tab] 2 leg dynaclip staple and rev.01 design of ed-10869.[tab] did not optimize even distribution of strain across the legs during high stress loading conditions.Review of the imaging provided shows that the breakage in this staple occurred in the general region with the highest for potential strain on the leg as was determined in cro-2021-0081 fea maximum loading condition analysis.While no injuries, incidents or pain was reported between the time of original implantation to the time of the reported of staple breakage, it can be concluded the 1 or more events may have occurred in the patient post-operatively that were similar to the maximum loading conditions in fea analysis, as the breakage was in the location of highest potential strain concentration.Following manufacturing of the complaint staple unit, the design of both the 2-leg staple (ed-10697) and the 4 leg inline staple (ed-10869) were revised from rev.01 to rev.02 under cro-2021-0081.As this event had reported patient pain, requiring removal of the broken staple, a 30-day mdr report was filed to fda as per qs-8.2.1.7, sop, medical device reporting.Qsf-8.2.1.2, health risk assessment form was completed and approved for this complaint, which determined that no market recall / removal was necessary.The occurrence rate of staples breaking with a cause attributable to the old revision design is approximately (b)(4).Despite the staple breakage and removal, both staples functioned properly to facilitate full bone fusion.As the design change to improve the strain profile of dynaclip 2-leg and 4-leg staples has been completed in may 2021, no further corrective actions are necessary at this time for the reasons listed above and based on completed health risk assessment form qsf-8.2.1.2.

• Brand Name: DYNACLIP 2-LEG STAPLE
• Type of Device: STAPLE, FIXATION, BONE
• 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: justin lovelace ; 1575 northside dr nw; suite 440; atlanta, GA 30318 ; 4805161552
• MDR Report Key: 18682059
• MDR Text Key: 335073674
• Report Number: 3007593722-2024-00001
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181781
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male