MAUDE Adverse Event Report: ARTHREX, INC. SCREW, CANCELLOUS, LOW PROFILE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	SCREW, CANCELLOUS, LOW PROFILE
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Swelling (2091); Burning Sensation (2146)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested for evaluation but was not returned therefore the complainant's event could not be verified.The device remains in patient.Device history record review revealed nothing relevant to this event; no issues were found with the sterilization of this lot.This device is supplied sterile.Based on the information provided, a definitive cause for the post-operative infection could not be determined.A most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.
Event or Problem Description
It was reported that the patient underwent an acl reconstruction procedure on 3/15/2019 where the following devices were implanted: ar-1349m/lot: 10253224/qty: 1; ar-1355/lot: 10249019/qty: 1; ar-7500/lot: 100038/qty: 1.After the surgery, infection of resident bacteria was observed around the post screw on the tibial side.Whether the sterilization and procedures of instruments used for surgery were appropriate is currently under investigation by the facility.Additional information has been requested.Additional information provided 4/2/2019: three days after the procedure, the patient experienced over 40°c fever and redness, mild swelling of lower right thigh proximal part, and feeling of heat.5 days after, blood was taken and inflammatory response was high.

• Brand Name: SCREW, CANCELLOUS, LOW PROFILE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8500756
• Report Number: 1220246-2019-01033
• Device Sequence Number: 1884752
• Product Code: MAI
• UDI-Device Identifier: 00888867013865
• UDI-Public: 00888867013865
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2019

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 Expiration Date: 09/30/2023
• Device Model Number: SCREW, CANCELLOUS, LOW PROFILE
• Device Catalogue Number: AR-1355
• Device Lot Number: 10249019
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 04/10/2019
• 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