MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,SS 4.0X 16MMCANCLUS; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,SS 4.0X 16MMCANCLUS
Health Effect - Clinical Codes	Pain (1994); Swelling (2091); Reaction (2414)
Date of Event	05/01/2015
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 various arthrex screws implanted during an ankle fixation procedure.The allergan office contacted arthrex requesting material compositions of the implanted product as they are concerned that the patient may be having an allergic reaction to the metals in the screws.The following arthrex part numbers were provided by the allergist; ar-8840-16, ar-8840cl-35, ar-8840cl-40.The allergist is requesting the material compositions of the screws to test the patient for the appropriate metals.At this time no additional details or information has been provided to arthrex regarding the type of symptoms the patient is experiencing, and/or the specific case details.Additional information received on 02/13/2020: the allergist reported the original procedure took place in (b)(6) 2014.The patient was experiencing swelling and pain, and a revision procedure was performed in (b)(6) 2015.The implanted screws were removed during the revision procedure.The allergist reported the patient is currently experiencing ankle pain and swelling years after having the screws completely removed.

• Brand Name: LO-PRO SCRW,SS 4.0X 16MMCANCLUS
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9756706
• Report Number: 1220246-2020-01727
• Device Sequence Number: 19529869
• Product Code: HWC
• UDI-Device Identifier: 00888867047778
• UDI-Public: 00888867047778
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: LO-PRO SCRW,SS 4.0X 16MMCANCLUS
• Device Catalogue Number: AR-8840-16
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other