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

Model Number	5.5MM BC CORKSCREW FT W/ SUTURETAPE
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
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 a shoulder arthroscopy three devices from the article ar-1927bct (lot 11567964) broke during screwing in.No broken parts remained inside the patient.According to the surgeon no harm for patient, operator or third party occurred.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.
Additional Manufacturer Narrative
Complaint confirmed.Three unpackaged ar-1927bct corkscrew suture anchors (no batch indicators present) were received for investigation.Visual inspection identified that the three bio-composite corkscrew anchors remained in various states of breakage at the distal ends of each suture anchor assembly.It was determined that the longest of the anchors measured at 14.27mm.The second longest had split into two fragments, with one piece measuring in at 8.53mm, and the other portion measuring 6.05mm.The third, smallest returned anchor measured only 4.58mm.No abnormalities were observed with the suture anchor drive assemblies.It was noted that the method of bone preparation used, 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 devices during insertion.

• Brand Name: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11647666
• Report Number: 1220246-2021-02875
• Device Sequence Number: 14411156
• Product Code: MAI
• UDI-Device Identifier: 00888867251267
• UDI-Public: 00888867251267
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/17/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 5.5MM BC CORKSCREW FT W/ SUTURETAPE
• Device Catalogue Number: AR-1927BCT
• Device Lot Number: 11567964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2021
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/17/2021
• Patient Sequence Number: 1