MAUDE Adverse Event Report: OSTEOMED SYSTEM, FIXATION, SHAPE MEMORY, 10X10; SYSTEM, FIXATION, SHAPE MEMORY, 10 X 10

Catalog Number 400-3703-SP

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/31/2018

Event Type  Injury  

Event Description

On 06/01/2018, osteomed was notified of an incident concerning one of our instafix staple devices.Per the sales representative, a standard akin osteotomy was perfomred on the great toe.An 8x8 instafix (p/n 400-3701) was used for fixation.An x-ray was then taken to confirm alignment.The interoperative x-ray showed the osteotomy was now displaced and the staple was compressed completely, both legs of implant were touching.It was explanted and we drilled new wholes for a 10x10 instafix staple (400-3703).An x-ray was taken and this staple also over compressed.The hinge of the bone also now appeared to have been broken.The staple was then explanted and two crossing k-wire were used to fixate the osteotomy.The wound was closed.On 07/31/2018, osteomed received additional information that the over-compression caused the bone to break.The bone was not broken prior to placement of the second staple.The two crossing k-wires were placed to fixate both the bunion and the broken hinge on the bone.

Manufacturer Narrative

The root cause of why the phalange bone broke after implantation of the instafix 10mm x 10 mm staple could not be determined.According to the information supplied by the sales rep, the patient did not have good bone quality.This is a direct contraindication for use of the implant per the instafix ifu.The rep also noted that it is "not uncommon" for this bone to break during the akin osteotomy surgical procedure.Another possibility is the over-compression of the 10x10 staple.This particular issue is under investigation via an internal capa.The review of dhr did not identify any non-conformances with release.A two-year review identified the capa which was opened due to this issue.A two-year review of the ncr database did not show any ncr's related to this implant.A two-year review showed this to be the second complaint where this staple contributed to fracturing a bone post-implantation.This issue will be monitored through routine trending.

• Brand Name: SYSTEM, FIXATION, SHAPE MEMORY, 10X10
• Type of Device: SYSTEM, FIXATION, SHAPE MEMORY, 10 X 10
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 7737271
• MDR Text Key: 115649985
• Report Number: 2027754-2018-00022
• Device Sequence Number: 0
• Product Code: JDR
• PMA/PMN Number: K141550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400-3703-SP
• Device Lot Number: 20620401802
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/31/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 07/31/2018
• Supplement Dates FDA Received: 08/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR