MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM KNOTLESS CORKSCREW, PEEK; SCREW, FIXATION, BONE

Model Number	3.9MM KNOTLESS CORKSCREW, PEEK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/18/2019
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.Devices were reported to have been discarded.The root 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 superior capsule repair (scr) with four anchors the threads tore off.Two anchors were left in the patient and two were removed from the patient.In order to remove the anchors, the surgeon needed to change the surgical technique to an open procedure.The surgery was finished successfully with a new device with the same part number.It was not necessary to do a second surgery.Update 21-jun-2019: the anchors left in the patient are reported to be fixed and cannot move.No further anchors were put on it.It was also reported that no consequences are expected for the patient.An additional cut was made to better access the surgical area.

• Brand Name: 3.9MM KNOTLESS CORKSCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8739514
• Report Number: 1220246-2019-01185
• Device Sequence Number: 13850758
• Product Code: HWC
• UDI-Device Identifier: 00888867270794
• UDI-Public: 00888867270794
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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 Expiration Date: 02/28/2023
• Device Model Number: 3.9MM KNOTLESS CORKSCREW, PEEK
• Device Catalogue Number: AR-1941PS
• Device Lot Number: S705604
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2019
• Initial Report FDA Received Date: 06/27/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other