MAUDE Adverse Event Report: ARTHREX, INC. HEADLESS COMPRES SCRW 6.5X75MM SHT THD; SCREW, FIXATION, BONE

Catalog Number	AR-8643-55
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/28/2017
Type of Reportable Event	Serious Injury
Additional 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 two submissions from the same case.The other is (b)(4).Lot number was not provided so device history record review cannot be performed.The device was requested for evaluation but remained in the patient therefore the complainant's event could not be verified.Another non-arthrex device was also used in the procedure.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.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a subtalar fusion case the following items were implanted: arthrocell, 2.5cc ((b)(4)), 6.5x80mm headless compress screw ((b)(4)) and 4.3x55mm headless compression screw ((b)(4)).The patient has since developed an infection at the site.A culture has been done and came up negative.
Additional 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 two follow up submissions from the same case.The other is (b)(4).Lot number was not provided so device history record review cannot be performed.The device was requested for evaluation but remained in the patient therefore the complainant's event could not be verified.Another non-arthrex device was also used in the procedure.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.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a subtalar fusion case the following items were implanted: arthrocell, 2.5cc (line 198894), 6.5x80mm headless compress screw (line 198895) and 4.3x55mm headless compression screw (line 198896).The patient has since developed an infection at the site.A culture has been done and came up negative.Follow up investigation: it was reported that the patient developed draining and odor from the surgical wound.On (b)(6) 2017 the patient was admitted to the hospital for implant removal, wound care, iv antibiotics and picc line for outpatient iv antibiotics.The patient's culture was positive for staphylococcus aureus.The patient will continue iv antibiotic via picc line for a minimum of 6 weeks due to done involvement.No further surgery is indicated at this time.
Additional Manufacturer Narrative
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 two follow up submissions from the same case.The other is (b)(4).Lot number was not provided so device history record review cannot be performed.The device was requested for evaluation but the device was discarded by facility therefore the complainant's event could not be verified.Another non-arthrex device was also used in the procedure.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.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a subtalar fusion case the following items were implanted: arthrocell, 2.5cc ((b)(4)), 6.5x80mm headless compress screw ((b)(4)) and 4.3x55mm headless compression screw ((b)(4)).The patient has since developed an infection at the site.A culture has been done and came up negative.Follow up investigation: it was reported that the patient developed draining and odor from the surgical wound.On (b)(6) 2017 the patient was admitted to the hospital for implant removal, wound care, iv antibiotics and picc line for outpatient iv antibiotics.The patient's culture was positive for staphylococcus aureus.The patient will continue iv antibiotic via picc line for a minimum of 6 weeks due to bone involvement.No further surgery is indicated at this time.

• Brand Name: HEADLESS COMPRES SCRW 6.5X75MM SHT THD
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6724216
• Report Number: 1220246-2017-00267
• Device Sequence Number: 1246692
• Product Code: HWC
• UDI-Device Identifier: 00888867126046
• UDI-Public: 00888867126046
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K132217
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/01/2017

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 Catalogue Number: AR-8643-55
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 06/30/2017; 06/30/2017
• Initial Report FDA Received Date: 07/19/2017
• Supplement Report FDA Received Date: 08/28/2017; 08/31/2017
• 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