MAUDE Adverse Event Report: OSTEOMED EXTREMIFIX; 3.0MM X 34MM CANNULATED HEADLESS SCREW

Catalog Number	317-3034
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2019, osteomed was notified of an incident concerning one of our cannulated headless screws.Per the distributor, the physician performed an mtp fusion on a patient in 2017.He used a 3.0 cannulated screw and 4.0 cannulated screw to gain join compression.Another physician from the office contacted the distributor to request his drivers to remove a broken 3.0mm cannulated screw.The distributor was not able to attend the procedure and followed up with the physician to find out if he was able to get the entire screw out.The physician stated that he was able to get ½ of the screw out, but the proximal ½ of the screw was left in.
Additional Manufacturer Narrative
The screw, a ø3.0mm x 34mm long cannulated headless screw, p/n 317-3034, was not returned for examination.Nor was any x-ray.The original surgery involved two cannulated headless screws being implanted in the mtp joint.The longer screw, a ø4.0mm x 52mm long cannulated headless screw, p/n 317-4052, was explanted two months post-op.The screw in question was extracted sixteen months after implantation.The screw had broken at some point between two months and sixteen months post-op.The joint did not fuse in all that time.Communication with the surgeons' staff did not reveal any patient health issues that might have slowed or eliminated the joint fusion.The surgeons' notes did not reveal any non-compliant activities of the patient.The root cause for the non-union could not be determined.There was no lot number provided.Therefore, a reveiw of the device history record (dhr) for the lot associated with this screw could not be performed.A two-year review did not identify any capas or ncrs related to this screw family, p/n 317-30xx.This is the only complaint for this issue within the last two years.This screw is a part of the extremifix headless cannulated screw system.The extremifix risk document includes an assessment of this failure mode.Per the fmea, the risk has a predicted severity rating of a 3.Per the risk management procedure, a rating of 3 indicates a "serious" severity level (results in injury or impairment requiring professional medical intervention).The final predicted risk level is a "medium".The extremifix instructions for use (ifu) warns the user that this screw family is not intended to endure excessive abnormal functional stresses.It also states that these screws are intended for temporary fixation only until osteogenesis occurs.This issue will be monitored through routine trending.

• Brand Name: EXTREMIFIX
• Common Device Name: 3.0MM X 34MM CANNULATED HEADLESS SCREW
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8396962
• Report Number: 2027754-2019-00005
• Device Sequence Number: 2326660
• Product Code: HWC
• UDI-Device Identifier: 00845694027489
• UDI-Public: 00845694027489
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K063298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 317-3034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention