MAUDE Adverse Event Report: MEDSHAPE, INC. ECLIPSE SOFT TISSUE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Device Problem Entrapment of Device (1212)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165); Swelling/ Edema (4577)

Event Date 05/12/2022

Event Type  Injury  

Event Description

Medshape was notified regarding a patient who had pain and swelling at the calcaneus and came in for review to find out that a small fragment of the implanted eclipse device had remained at the surgical site.

Manufacturer Narrative

The removal is set to occur at the end of (b)(6) 2022 and further details will be obtained.The patient information, original implant date and lot information are unknown at this time.Additional reporting on this event will be provided as a supplemental report to this document if it becomes available.

Manufacturer Narrative

Complaint (b)(4) investigation was completed on 01jul2022.In conclusion, the most probable root cause of this complaint has been determined to be an error made by the surgeon during the original implantation case in (b)(6) 2021 resulting in a breakage of the eclipse metal end of the cannula.Additionally, there was a failure to detect that part of the metal retention rod remained with the eclipse implant at the surgical site, as is specified in mk-10091 eclipse ifu step 11.Review of complaint history shows that for (b)(4).Thus, due to the overall low complaint / sales rate for this failure mode, no corrective action is necessary to address this issue or the fact that there was a lack of observation of this issue during the initial surgery.However, during this investigation it was observed that this failure mode of "metal component of eclipse delivery rod breaks and remaining in patient post-operatively" is not captured in ed-50142 eclipse risk management document.Thus, despite a low complaint rate, an analysis is needed into the full risk to the patient of any of the metal components of the delivery rod remaining in the patient post-operatively.Capa 2022-07-001 has been initiated to evaluate the eclipse risk assessment documents and determine if an update is needed to address this failure mode.The results of this assessment will also determine if additional actions may be necessary for the eclipse design, manufacturing process or surgical technique based on the risk of this metal remaining in the patient post-operatively.Despite the observation that the risk assessment for eclipse needs a new evaluation for this failure, the investigation determined that the existing manufacturing process controls and surgical technique / ifu are adequate and do not need modification at this time.

• Brand Name: ECLIPSE SOFT TISSUE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): MEDSHAPE, INC.; 1575 northside dr nw; suite 440; atlanta, GA 30318
• Manufacturer Contact: justin lovelace ; 1575 northside dr nw; suite 440; atlanta, GA 30318
• MDR Report Key: 14597001
• MDR Text Key: 293347103
• Report Number: 3007593722-2022-00001
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: 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: 54 YR
• Patient Sex: Female