MAUDE Adverse Event Report: ARTHREX, INC. LOW PROFILE SCREW, TI, 4.5 X 34MM; PLATE, FIXATION, BONE

Model Number	LOW PROFILE SCREW, TI, 4.5 X 34MM
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/02/2020
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 by the patient's legal representative that the patient had sustained a work injury on (b)(6) 2019, injuring a variety of body parts in that fall.Patient sustained injuries to his right lower extremity.Since the injury the patient has undergone several procedures on his right lower extremity.On (b)(6) 2019 - external fixator implanted.At some point after the initial surgical procedure on (b)(6) 2019, patient's right lower extremity became severely infected.On (b)(6) 2019 - external fixator removed and orif conducted on right tibial pilon.The product implanted in the patient during the april procedures were another manufacturer's product (non-arthrex).On (b)(6) 2019 - irrigation and debridement, hardware removal, insertion of antibiotic beads and spacer.On (b)(6) 2019 - irrigation and debridement, re-insertion of antibiotic beads and spacer.On (b)(6) 2019 - debridement and preparation of wound, skin transfer from right thigh, exchange of antibiotic spacer.Patient was treated for infection after the (b)(6) 2019 procedures until just prior to the (b)(6) 2019 procedure where arthrex products were implanted.On (b)(6) 2019 - irrigation and debridement, antibiotic spacer exchange, bone biopsy and culture.On (b)(6) 2019 - removal of antibiotic spacer, ankle fusion using arthrex ttc fusion plate.During the (b)(6) 2019 procedure the following devices were implanted: ar-8970pl, lot 5261604, ankle fusion plate, posterior ttc, left, ar-8545-28, lot 10255239, low profile screw 4.5 x 28mm, ar-8545-34, lot 10236575, low profile screw 4.5 x 34mm, ar-8545-38, lot 10188917, low profile screw 4.5 x 38mm, ar-8545l-26, lot 1051631, low profile locking screw, 4.5 x 26mm, ar-8545l-30, lot 1059964, low profile locking screw 4.5 x 30mm, ar-8545l-34, lot 1056073, low profile locking screw 4.5 x 34 mm, ar-8545l-38, lot 1058918, low profile locking screw, 4.5 x 38mm.On (b)(6) 2019 - irrigation and debridement, wound vac application.On (b)(6) 2020 - irrigation and debridement, complete removal of hardware (presumed to be all arthrex hardware implanted on (b)(6) 2019), and placement of incisional wound vac.

• Brand Name: LOW PROFILE SCREW, TI, 4.5 X 34MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 9751145
• Report Number: 1220246-2020-01709
• Device Sequence Number: 19557256
• Product Code: HRS
• UDI-Device Identifier: 00888867124561
• UDI-Public: 00888867124561
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K141735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: LOW PROFILE SCREW, TI, 4.5 X 34MM
• Device Catalogue Number: AR-8545-34
• Device Lot Number: 10236575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 47 YR