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

Catalog Number	AR-15555BC
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported via facility medwatch report (b)(4) the during a left split anterior tibial tendon transfer procedure the surgeon was implanting the ar-1555bc screw and the screw broke.The distal portion of the screw was retained in the patient's bone.The proximal portion of the screw above the break was retrieved and save by the facility ors quality as well as the device box with implant numbers.Patient was a (b)(6) male.(b)(6) kg.Non-hispanic/latino follow-up investigation: date of procedure was (b)(6) 2018.To complete the procedure a different size of the same arthrex screw was used and placed in another location.Facility has the device to return for evaluation.

• Brand Name: TENODESIS SCREW, BIOCOMPOSITE
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7439303
• Report Number: 1220246-2018-00144
• Device Sequence Number: 19118683
• Product Code: HWC
• UDI-Device Identifier: 00888867018853
• UDI-Public: 00888867018853
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/18/2018

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: 02/01/2019
• Device Catalogue Number: AR-15555BC
• Device Lot Number: 10128592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2018
• Initial Report FDA Received Date: 04/18/2018
• 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
• Patient Age: 58 YR
• Patient Weight: 106