MAUDE Adverse Event Report: ARTHREX, INC. TENODESIS SCREW, PEEK; SCREW, FIXATION, BONE

Model Number	TENODESIS SCREW, PEEK
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/26/2020
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 peek tenodesis screws, ar-1530ps, were being used in a ucl reconstruction procedure.When the surgeon went to insert one of the screws into the prepared bone, the distal tip of the driver broke off into the head of the screw.The surgeon was unable to remove the tip fragment from the screw and it remained in the head of the screw in the patient.The second peek screw was implanted without any issue.
Event or Problem Description
Additional information provided 5/28/2020: the tip from three drivers broke however there were only two fragments from two drivers that were left in the patient.There was one additional driver that was returned for evaluation.This fourth driver was also used in the procedure but it is unlikely that the tip broke.
Additional Manufacturer Narrative
The following additional information obtained has been added to section b5: additional information provided 5/28/2020: the tip from three drivers broke however there were only two fragments from two drivers that were left in the patient.There was one additional driver that was returned for evaluation.This fourth driver was also used in the procedure but it is unlikely that the tip broke.Complaint confirmed, the hexagonal drive feature of three drivers were broken.The 4th device was returned undamaged.The devices were found to meet specifications.Likely causes of the event include improper bone prep, misaligned insertion, prying/leveraging the device during insertion.

• Brand Name: TENODESIS SCREW, PEEK
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9838293
• Report Number: 1220246-2020-01763
• Device Sequence Number: 2886736
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 06/03/2020

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: 03/31/2024
• Device Model Number: TENODESIS SCREW, PEEK
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 10301579
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other