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	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
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 a shoulder arthroscopy took place.The arthrex device ar-1927bcf-1 was used which broke during insertion.The surgeon decided that the anchor is stable enough so there is no need to remove the anchor or use a second device.The broken fragment of the anchor was completely removed.There was no harm for patient, operator or third party reported.The surgery was finished successfully with this device.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation revealed the distal end of the bio-corkscrew is broken off.A most likely cause for this event to occurred is by not inserting the implant co-axial to the bone tunnel or continually prying/leveraging the driver while the implant is still loaded.

• 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: 8637231
• Report Number: 1220246-2019-01111
• Device Sequence Number: 13914614
• 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): 07/18/2019

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: 12/31/2020
• Device Model Number: SUTURE ANCHOR, BIO-CORKSCREW FT
• Device Catalogue Number: AR-1927BCF-1
• Device Lot Number: 10271705
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/30/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other