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

Catalog Number	AR-1530PS
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.This is one of two submissions for the same patient event.The other is 1220246-2016-00587 ((b)(4) (b)(6)).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.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event include continually applying torque after the screw is fully seated, torquing when the implant is not properly aligned and/or leveraging, torquing while leveraging the device.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
Tenodesis¿ screw with handled inserter, ar-1530ps lot: 1189487 ((b)(4) (b)(6)) broke off while being screwed in.The broken tip was not retrieved and is still in the patient.Another peek-tenodesis¿ screw with handled inserter ar-1530ps (same lot) also broke in the same manner but this was retrieved.A biocomposite-tenodesis¿ screw with handled inserter, ar-1530bc lot: 1362942 ((b)(4) (b)(6)) was also used and the tip of this device also broke off into the patient and was not retrieved.One each of an ar-1530ps and ar-1530bc were used to complete the procedure.

• 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: 6184922
• Report Number: 1220246-2016-00586
• Device Sequence Number: 10785454
• Product Code: HWC
• UDI-Device Identifier: 00888867018662
• UDI-Public: 00888867018662
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 12/19/2016

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: 07/01/2019
• Device Catalogue Number: AR-1530PS
• Device Lot Number: 1189487
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2016
• Initial Report FDA Received Date: 12/19/2016
• 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