MAUDE Adverse Event Report: ARTHREX, INC. SUTR ANCH,CRKSCRW; SCREW, FIXATION, BONE

Model Number	SUTR ANCH,CRKSCRW
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/08/2018
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 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 an ankle ligamentoplasty surgery the anchor broke during the introduction into the lateral malleolar tip.The location was well prepared prior to implementation, with a pin.It was impossible to extract the anchor, and difficult to put the second one, because of the anchor that remained in place.The surgery was lengthened by 45 minutes.It was not possible to remove the broken fragment.The surgery was completed successfully with a new device of the same part number.

• Brand Name: SUTR ANCH,CRKSCRW
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7841974
• Report Number: 1220246-2018-00617
• Device Sequence Number: 13949805
• Product Code: HWC
• UDI-Device Identifier: 00888867022652
• UDI-Public: 00888867022652
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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: 11/30/2022
• Device Model Number: SUTR ANCH,CRKSCRW
• Device Catalogue Number: AR-1915SF
• Device Lot Number: F180363
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other