MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT II; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, CORKSCREW FT II
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/17/2018
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.A portion of the device remains in the patient and the remaining portion 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 a achilles tendon refixation surgery they tried to insert part number ar-1928snf-2 into the calcaneus.During insertion the device broke but it was deep enough that the partial anchor could be left inside the patient.The breakpoint of the anchor was located at the thread of the connection between anchor and driver.It was not possible to remove the thread.The fragment will remain inside the patient.The surgery was finished successfully with the same devices.It was not necessary to switch the surgical technique or do a second surgery.The device will not be sent in for evaluation because it was discarded by the customer.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT II
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8235153
• Report Number: 1220246-2019-00847
• Device Sequence Number: 1929174
• Product Code: HWC
• UDI-Device Identifier: 00888867023703
• UDI-Public: 00888867023703
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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 Model Number: SUTURE ANCHOR, CORKSCREW FT II
• Device Catalogue Number: AR-1928SNF-2
• Device Lot Number: 10165729
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/10/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other