MAUDE Adverse Event Report: ARTHREX, INC. RETROFUSION SCREW, 20MM; PLATE, FIXATION, BONE

Model Number	RETROFUSION SCREW, 20MM
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/28/2018
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 not returned for evaluation.The device was reported to have been discarded.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 screwing in the retrofusion screw with moderate force, the device bent.When the surgeon tried to unscrew the device the screw broke on the proximal part.It was not possible to retrieve the broken fragment.It will remain inside the toe.The performed surgery was an proximal interphalangeal joint arthrodesis.The surgery was completed successfully with a k-wire.

• Brand Name: RETROFUSION SCREW, 20MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7713376
• Report Number: 1220246-2018-00565
• Device Sequence Number: 1120765
• Product Code: HRS
• UDI-Device Identifier: 00888867187825
• UDI-Public: 00888867187825
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K141725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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 Expiration Date: 06/30/2022
• Device Model Number: RETROFUSION SCREW, 20MM
• Device Catalogue Number: AR-4157-20
• Device Lot Number: 10149102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/24/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other