MAUDE Adverse Event Report: ARTHREX, INC. LOW PRO SCRW,TI,4.5X 60MMCANN PT THD; PLATE, FIXATION, BONE

Catalog Number AR-8967-2885

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Device Or Device Fragments Location Unknown (2590)

Patient Problems Bacterial Infection (1735); Fluid Discharge (2686)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.This is one of six complaints being submitted from the same event, the others are (b)(4).Lot number was not provided so device history record review cannot be performed.The device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.Arthrex's 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.If additional relevant information is received, a follow-up report will be submitted.Facility will not return the device.

Event Description

It was reported that the patient underwent a triple arthrodesis procedure on (b)(6) 2016.Around (b)(6) 2016, the patient noticed drainage from a small opening in his left lateral foot incision.The patient tested positive for prevotella disiens beta lactamase and tested negative for finegoldia magna beta lactamase and gemella morbillorum beta lactamase.The patient was prescribed 500 mg of keflex twice a day for 7 days.Surgeon had planned a revision to remove only the two 4.5 mm screws that were in closest proximity to the infected area however, the patient's infection control doctor wanted for all the hardware to be removed.Revision took place (b)(6) 2017.While removing the hardware from the (b)(6) 2016 triple arthrodesis, the tip of the 3.5 cannulated hex driver, ar-8967d, lot unknown, ((b)(4)) broke into multiple pieces.The surgeon had started the removal of the 6.7 mm screw with the driver on a ratcheting handle, and on his first attempt of using power, the hex driver broke.All pieces were removed and accounted for except for one, it was not found in the sterile field and the surgeon could not see anything large enough on x-ray to go after before closing.The scrub tech had thrown away the broken driver in the sharps container at time of procedure.The remaining screws were removed using another 3.5 cannulated hex driver from the set.The following lo-pro screws were explanted during the procedure: ar-8967-1895, 6.7 x 95 mm, ((b)(4)); ar-1867-2885, 6.7 x 85 mm, ((b)(4)); ar-8945-45pt, 4.5 x 45 mm ((b)(4)); ar-8945-60pt, 4.5 x 60 mm, ((b)(4)); ar-8945-40pt, 4.5 x 40 mm ((b)(4)).Screw lot numbers were not available.Explanted screws were discarded at time of procedure.

• Brand Name: LOW PRO SCRW,TI,4.5X 60MMCANN PT THD
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath, sr mdr analyst ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 6352227
• MDR Text Key: 68097537
• Report Number: 1220246-2017-00038
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00888867053762
• UDI-Public: 00888867053762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-8967-2885
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other