MAUDE Adverse Event Report: ARTHREX, INC. INTSCRW RD DELTATPR W/DISP SHTH 10X28MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	INTSCRW RD DELTATPR W/DISP SHTH 10X28MM
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Pain (1994); Swelling (2091)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was requested for evaluation but device disposition is unknown, therefore the complainant's event could not be verified.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.The 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 needed to have the devices removed post-op due to infection.Original dos (b)(6) 2018 for acl with hamstring autograft.Patient is (b)(6) yo male, who presented with pain, redness, swelling.A culture showed staph infection and the devices were removed.
Additional Manufacturer Narrative
The device was requested for evaluation but device disposition is unknown, therefore the complainant's event could not be verified.A 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.The most likely cause for this type of event is a nosocomial source or patient non-compliance with post-op wound care directions.

• Brand Name: INTSCRW RD DELTATPR W/DISP SHTH 10X28MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7873257
• Report Number: 1220246-2018-00641
• Device Sequence Number: 2050058
• Product Code: MAI
• UDI-Device Identifier: 00888867035393
• UDI-Public: 00888867035393
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K062466
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 12/31/2022
• Device Model Number: INTSCRW RD DELTATPR W/DISP SHTH 10X28MM
• Device Catalogue Number: AR-5028P-10
• Device Lot Number: 10185995
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 09/02/2021
• 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