MAUDE Adverse Event Report: OSTEOMED 4.0MM HEADLESS CANNULATED SCREWS; 4.0MM X 52MM CANNULATED HEADLESS SCREW

Catalog Number	317-4052
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw, a ø4.0mm x 52mm long cannulated headless screw, p/n 317-4052, was not returned for examination.Some x-rays were supplied.The original surgery involved two cannulated headless screws being implanted in the mtp joint.The longer screw, the screw in question, a ø4.0mm x 52mm long cannulated headless screw, p/n 317-4052, was explanted two months post-op.The second screw was extracted sixteen months after implantation.The second 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, no review of the dhr was possible.A two-year review did not identify any capas or ncrs related to this screw family, p/n 317-40xx.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 risk document, this type of issue has a severity of 3, which correlates to a serious severity - 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.
Event or Problem Description
On (b)(6) 2019, osteomed was notified of an adverse event concerning our 4.0mm x 52mm cannulated headless screw.While reviewing information obtained for a complaint, it was identified that another screw implant was explanted in 2017.Therefore, this complaint was initiated for the explanted device.Per the information received from the distributor, within the operative notes concerning the patient associated with complaint (b)(4), the original surgery was on (b)(6) 2017.At some point the patient complained of pain, and on (b)(6) 2017 the implant was removed.Complaint (b)(4) was previously reported under mdr# 2027754-2019-00005.

• Brand Name: 4.0MM HEADLESS CANNULATED SCREWS
• Common Device Name: 4.0MM X 52MM CANNULATED HEADLESS SCREW
• Manufacturer (Section D): OSTEOMED; 3885 arapaho road; addison TX 75001
• MDR Report Key: 8452479
• Report Number: 2027754-2019-00007
• Device Sequence Number: 19555032
• Product Code: HWC
• UDI-Device Identifier: 00845694027694
• UDI-Public: 00845694027694
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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: 317-4052
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial 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
• Patient Age: 68 YR