MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS MEMOFIX STAPLE 15MM X 12MM X 12MM; MEMOFIX STAPLE SYSTEM

Catalog Number MS151212

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Erosion (1750); Bone Fracture(s) (1870); Implant Pain (4561)

Event Date 08/13/2021

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

1 of 2 reports.Other mfg report number: 1651501-2021-00036.A physician reported a patient underwent primary left wrist 4-corner arthrodesis and 5 months postop of primary fusion, the patient presented with left wrist pain, loose hardware with evidence of capitolunate nonunion.Patient required revision surgery.The revision surgery included hwr, revision midcarpal fusion.Intraoperative findings of revision surgery included severe erosive changes of capitate and lunate, as well as fracture dorsal 1/3 of lunate rim due to loose staples.Revision midcarpal fusion required autologous bone graft, allograft, headless compression screws and k-wires.

Manufacturer Narrative

Memofix staple was returned for evaluation: failure analysis: the return included four (4) staples total; three of the staples appeared to be the same, larger size while the remaining single staple is smaller.Visual examination of the staples identified no damage or deformity.As no physical indications of failure were identified on the returned parts and x-rays were not provided to show the staples in-situ, the failure could not be confirmed.Root cause: a definitive root cause for the non-union of the memofix staples cannot be determined.According to risk documentation for the memofix system, potential causes for non-union of the implant resulting in on-going pain include inadequate design and inadequate or incorrect surgical technique.According to the instructions for use (ifu) for the memofix system, "use of the staple system is contraindicated.In patients with high levels of activity; [and] in patients who are not able to comply with post-operative treatment protocols".It also mentions possible adverse effects, including "migration/loosening of the implant.[and] fracture of the implant due to non-compliance to post-operative regimen, improper implant selection, or non-union.".

Event Description

N/a.

• Brand Name: MEMOFIX STAPLE 15MM X 12MM X 12MM
• Type of Device: MEMOFIX STAPLE SYSTEM
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX
• MDR Report Key: 12377228
• MDR Text Key: 268460065
• Report Number: 1651501-2021-00035
• Device Sequence Number: 1
• Product Code: JDR
• Combination Product (y/n): N
• PMA/PMN Number: K123926
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MS151212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1