MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3X 32MMCANN,PT THD; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3X 32MMCANN,PT THD
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that during a 1st mtp fusion procedure while using the forefoot fusion module tray, the surgeon used two ar-8933-32pt, 3.0 low profile cannulated partially threaded screws to fuse the joint, prior to using a plate for the fusion.The surgeon then used two ar-8933k, guide wire with trocar tips in crossing fashion to hold the fusion in place.The surgeon then measured, and over-drilled with the ar-8933-20c, cannulated drill bit to the near cortex of bone.Following drilling, the surgeon inserted screws over the guide wire using a cannulated hand driver.As the surgeon was advancing the screw, the surgeon stated they felt something unusual, and did not feel adequate compression.Using fluoroscopy, it was discovered that one of the ar-8933-32pt screws had broken in half in the patients bone.The surgeon was able to remove the head of the screw and the shaft, but was not able to retrieve the remainder of the screw as it was in the patient's bone.The rep confirmed that the screw head and the smooth screw shaft were able to be retrieved, but the threaded portion of the screw remains in the patient.The rep stated that the bone quality was decent.The rep confirmed that the case proceeded and the surgeon was able to obtain adequate compression on the fusion site with one screw and one mtp plate fixation.The rep confirmed that the retrieved portions of the screw will be returning to arthrex for evaluation.The rep stated they are not able to attain the lot number of the broken screw.Patient: female / age (b)(6) / dob: (b)(6).

• Brand Name: LO-PRO SCRW,TI,3X 32MMCANN,PT THD
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8084148
• Report Number: 1220246-2018-00759
• Device Sequence Number: 1599477
• Product Code: HWC
• UDI-Device Identifier: 00888867049772
• UDI-Public: 00888867049772
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/19/2018

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 Model Number: LO-PRO SCRW,TI,3X 32MMCANN,PT THD
• Device Catalogue Number: AR-8933-32PT
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/19/2018
• 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: Other
• Patient Age: 55 YR