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

Model Number	SUTURE ANCHOR, CORKSCREW FT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2019
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.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 two ar-1915ft-1, suture anchor corkscrew ft, were used for a brostöm repair in the fibula.Patient was a young male professional football player with hard bone quality.Although the correct steps were taken - cortex predrilling with k-wire which is included in the corkscrew package- both corkscrews broke off at the level of the screwdriver just above the corkscrew.Broken piece remains in patient.The surgery was finished successfully with a different device, part number ar-1915sf-1.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6), (b)(6) 2019: one screw is still half way inside patient.Surgeon had no means of taking it out again.The other screw was completely inside the bone and usable.The broken screw is fixed inside the fibula bone and stable.It will not move.A second anchor was used to complete the brostöm repair.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8587845
• Report Number: 1220246-2019-01078
• Device Sequence Number: 16553770
• Product Code: HWC
• UDI-Device Identifier: 00888867022614
• UDI-Public: 00888867022614
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2019

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: 08/31/2023
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT
• Device Catalogue Number: AR-1915FT-1
• Device Lot Number: 10235891
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 05/07/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other