MAUDE Adverse Event Report: ARTHREX, INC. 2.4 X 18MM VAL SCREW, TI; PLATE, FIXATION, BONE

Model Number	2.4 X 18MM VAL SCREW, TI
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/01/2020
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 a patient had undergone a procedure (b)(6) 2020.The first week of (b)(6) 2020 the patient had a follow up visit at the surgeon's office and x-rays taken during the follow up showed a foreign body is present.The item had not been seen on the intraoperative x-rays taken at the time of procedure.It was also reported that the foreign body is not causing any pain or discomfort to the patient.Surgeon believes that the foreign body may be a thin shaving from the narrow ulnar plate/plate screws that had been implanted.Surgeon also indicated that he has seen this occur previously with the arthrex system that was used.(information has been requested regarding these instances.) the shaving was not noticed at the time of occurrence to determine the specific product the shaving may have come from.At this time the surgeon does not have plans to remove the hardware or foreign body but the sales representative has requested that the surgeon notify him if a second surgery is scheduled.The following are the plate and screws that were used during the (b)(6) 2020 procedure: ar-8916vnl-03, volar distal radius plate, lot 10440051.Ar-8724-18, low profile screw, lot w652321.Ar-8724v-16, val screw, lot w689081.Ar-8724v-18, val screw, lot 1204022.Ar-8724v-18, val screw, lot w698661 ar-8735-10, low profile screw cortical, lot 2698961.Ar-8735-11, low profile screw cortical, lot 2689741.Ar-8735-13, low profile screw cortical, lot 2689771.Ar-8735-14, low profile screw cortical, lot 2716281.Ar-8735l-12, low profile locking screw, lot 2706701.Ar-8735l-14, low profile locking screw, lot 2706691.

• Brand Name: 2.4 X 18MM VAL SCREW, TI
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10460714
• Report Number: 1220246-2020-02103
• Device Sequence Number: 16785934
• Product Code: HRS
• UDI-Device Identifier: 00888867045613
• UDI-Public: 00888867045613
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/27/2020

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 Model Number: 2.4 X 18MM VAL SCREW, TI
• Device Catalogue Number: AR-8724V-18
• Device Lot Number: W698661
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/27/2020
• 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