MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.0MMX 18MMCORT; SCREW, FIXATION, BONE

Model Number	LO-PRO SCRW,TI,3.0MMX 18MMCORT
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Necrosis (1971); Pain (1994); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/05/2019
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 therefore the complainant's event could not be verified.The root cause of the event could not be determined from the information available and without device evaluation.A possible cause of this type of event may be a reaction of the patient to the material(s) implanted or used during the implant procedure.Patient sensitivity to materials must be considered prior to implantation.
Event or Problem Description
It was reported by the patient¿s legal representative that the patient underwent a left 1st metatarsophalangeal joint revision fusion and hardware removal, extraction of graft and weil osteotomy on (b)(6) 2017 due to painful nonunion of her left first metatarsophalangeal joint fusion.During the procedure the surgeon explanted a plate and lag screws from a previous procedure (date of previous procedure and explanted device manufacturer unknown at time of initial report).The surgeon utilized a 1.7 mm drill bit, ar-1201-7dc, for micro drilling through the fusion site in order to promote ingrowth and the drill bit snapped off intramedullary.The surgeon attempted to remove the drill bit fragment but was unable to because of the location.The operative report dated (b)(6) 2017 noted that removal of the drill bit fragment would cause more harm to the patient.The surgeon finished the surgery by performing a capsulotomy and weill osteotomy and implanted the following arthrex plate and screws: ar-8944cl-l (low profile mtp plate), ar-8730-38pt (quickfix screw), ar-8933-24 (low profile screw), ar-8933-18 (low profile screw), and ar-8933l-18 (qty 2) (low profile locking screw).In (b)(6) 2018, the patient presented with persistent pain and was evaluated for a left first mtp fusion non-union.The patient underwent a revision left first mtp i&d on (b)(6) 2018.The revision procedure was performed by a different surgeon at a different facility from the (b)(6) 2017 procedure.The operative report noted that upon exposing the plate necrotic appearing tissue surrounded the plate and it had a green/grey appearance.All of the locking screws in the plate were noted to be loose, with osteolysis surrounding them.The lag screw was also noted to be loose.All of the hardware and the bone graft were removed.The drill bit was then identified and removed.Due to the appearance of the tissue as well as the loose hardware; chronic, low-grade infection could not be ruled out.Therefore, full revision surgery was abandoned.The records indicated that any revision procedure would be performed at a later date in a staged fashion.All of the removed tissue, bone and hardware were sent for culture.The bone was sent to pathology.The procedure was completed by copiously irrigating the 1st mtp joint and an antibiotic-laden cement space was made and placed into the defect.

• Brand Name: LO-PRO SCRW,TI,3.0MMX 18MMCORT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8391609
• Report Number: 1220246-2019-00951
• Device Sequence Number: 1651560
• Product Code: HWC
• UDI-Device Identifier: 00888867049536
• UDI-Public: 00888867049536
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2019

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,TI,3.0MMX 18MMCORT
• Device Catalogue Number: AR-8933-18
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/05/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR