MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, BIO-CORKSCREW FT; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SUTURE ANCHOR, BIO-CORKSCREW FT
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/26/2019
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 during a shoulder arthroscopy, while the device was inserted, the anchor broke in half.The half broken anchor remained inside the patient.The surgery was completed successfully with a new device of the same part number.The other half of the broken screw will not be sent in for evaluation because it was discarded by the facility.The driver will be sent back for evaluation.No further information received.Update 01-oct-2019: the broken fragment of the screw is well fixed into the bone and cannot move.A new drill hole was necessary to place the new screw next to the broken screw.The surgery was performed on (b)(6) 2019.
Additional Manufacturer Narrative
The driver was returned without fragments, the complaint is not confirmed.The most likely causes of this event include improper bone prep, misaligned insertion, prying and/or leveraging the device during insertion.

• Brand Name: SUTURE ANCHOR, BIO-CORKSCREW FT
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9193159
• Report Number: 1220246-2019-01358
• Device Sequence Number: 19619608
• Product Code: MAI
• UDI-Device Identifier: 00888867096783
• UDI-Public: 00888867096783
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082810
• 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,Followup
• Report Date (Section B): 11/21/2019

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: 01/31/2021
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF-1
• Device Lot Number: 10278098
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 09/27/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other