MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW TM,SS 3.5X 16MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW TM,SS 3.5X 16MMCORT
Health Effect - Clinical Code	Pain (1994)
Date of Event	11/06/2019
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 devices were reported to have been given to the patient.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 left clavicle fracture procedure on (b)(6) 2019.Due to patient issues with painful hardware.The patient underwent a revision procedure (b)(6) 2019 at a different facility than the original surgery center.All original arthrex implants were explanted during the revision.No products were implanted during the revision procedure.The explanted devices are not available to return for evaluation.The products were kept by the patient.The following are the arthrex devices that were explanted: ar-2655cl, clavicle fracture plate, central third -left, (lot 5261832), ar-2665-14h, fragment screw, (lot 135138), ar-8835-16, low profile screw (qty 3), (lot 10240456), ar-8835-16, low profile screw (qty 3), (lot 10248912).

• Brand Name: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9473154
• Report Number: 1220246-2019-01485
• Device Sequence Number: 13505008
• Product Code: HWC
• UDI-Device Identifier: 00888867047297
• UDI-Public: 00888867047297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: LO-PRO SCRW TM,SS 3.5X 16MMCORT
• Device Catalogue Number: AR-8835-16
• Device Lot Number: 10240456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/16/2019
• 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