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

Catalog Number	AR-1655PS
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/21/2017
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.At this time, it cannot be determined how the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.Additional information has been requested but not made available.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Unknown device disposition.
Event or Problem Description
It was originally reported that the patient underwent an ac joint reconstruction on the right shoulder.The patient scheduled an appointment with his surgeon to identify something "funny" in his shoulder.The surgeon was able to remove some screws and the suture from the surgery.The surgeon plans on going in with a scope to clean out the patient's shoulder.Original part number information was not known at time of report and has been requested.Additional information received (b)(6) 2017: original date of implant ac joint reconstruction surgery was (b)(6) 2015.Part ar-1655ps, lot 1257190, qty 2 were implanted during the 2015 procedure.The suture and screw that were removed from the patient were removed in the surgeon's office.Surgeon was able to pull the suture out along with the screw himself after making a small incision.Only one screw is known to have been removed.The surgeon has decided not to schedule another procedure, as the patient has not returned complaining of any pain.

• 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: 6607847
• Report Number: 1220246-2017-00185
• Device Sequence Number: 13509330
• Product Code: HWC
• UDI-Device Identifier: 00888867020504
• UDI-Public: 00888867020504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 06/02/2017

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: 03/01/2020
• Device Catalogue Number: AR-1655PS
• Device Lot Number: 1257190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/02/2017
• 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