MAUDE Adverse Event Report: NEWDEAL SAS 2.5MM K-WIRE LENGTH, 200MM

Catalog Number 115225ND

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cyst(s) (1800); Bone Fracture(s) (1870); Necrosis (1971); Pain (1994); Ambulation Difficulties (2544)

Event Date 06/03/2011

Event Type  Injury  

Event Description

This is the fourth report of four reports concerning the same pt (see mfg report number 9615741-2014-00017).The device involved in the reported incident is a k-wire that was used for fixation during surgery on (b)(6) 2011.It was reported the pt (a healthcare professional) had surgery in her right foot due to pain due to flat feet.A talonavicular fusion, flexor tendon ligament repair, and a medical slide calcaneal osteotomy of the right foot was performed on (b)(6) 2011.At the time of surgery, three qwix screws were implanted.A k-wire was used for fixation.On a non-specified date after surgery the pt said she experienced pain in her right foot.In (b)(6) 2013, pt experienced pain in her foot and a magnetic resonance imaging (mri) which revealed a cyst in the right foot that 'had a hole in it' and avascular necrosis.Pt said she 'felt the k-wire that was used for the surgery and removed during surgery caused the cyst in her right foot'.On (b)(6) 2013, the pt experienced pain and said she thought the cyst 'broke' but a computed axial tomography (cat) scan revealed the cyst was present and increased in size.On (b)(6) 2013, pt had surgery to remove the cyst, bone grafting was done using auto-graft bone from her tibia and a subtalar fusion was performed.A cat on (b)(6) 2014 revealed a fracture in the right foot.Pt reported she still experiences pain when walking.On (b)(6) 2014 in direct conversation, the pt said she had an appointment with a different surgeon scheduled for (b)(6) 2014.On (b)(6) 2014, pt said she planned to cancel the appointment because she is looking for a job.Request was made by integra for additional info including the operative notes and diagnostic tests that were performed.

Manufacturer Narrative

The device involved in the reported incident is not available for eval.An investigation has been initiated based on the reported info.

• Brand Name: 2.5MM K-WIRE LENGTH, 200MM
• Type of Device: NA
• Manufacturer (Section D): NEWDEAL SAS; saint priest 6980 0; FR 69800
• Manufacturer Contact: caren finkelstein ; 315 enterprise dr; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 3827664
• MDR Text Key: 4502834
• Report Number: 9615741-2014-00020
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 115225ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR