MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC CORKSCREW FT W/ SUTURETAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	5.5MM BC CORKSCREW FT W/ SUTURETAPE
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
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 shoulder arthroscopy the screw of the ar-1927bct-1 anchor broke off inside the patient during placement.One part remains in the bone and the other was recovered.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update (b)(6) 2021: the remaining part is fixed well in the patient.It can´t move.Update (b)(6) 2021: a new hole was drilled to use a new device with the same part number.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1927bct-1 biocomposite corkscrew anchor (no batch number present) was received for investigation.It was determined using digital caliper id:011 that approximately 9.79mm of the corkscrew anchor remained.Four threads were present and fully intact.The fifth thread was partially broken, with nothing remaining past it.The method of bone preparation, as well as the bone quality encountered during the procedure, were not recorded.As such, the observed condition is most likely the result of improper bone preparation, off-axis insertion, and/or prying/leveraging the anchor during insertion.

• Brand Name: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11186244
• Report Number: 1220246-2021-02477
• Device Sequence Number: 767026
• Product Code: MAI
• UDI-Device Identifier: 00888867264595
• UDI-Public: 00888867264595
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 03/31/2022
• Device Model Number: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT-1
• Device Lot Number: 10784514
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other