MAUDE Adverse Event Report: ARTHREX, INC. DISPOSABLE KIT, TRANS-TIBIAL ACL WITH SAW BLADE; BLDE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number AR-1897S

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/30/2016

Event Type  Injury  

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.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.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.Device given to patient by facility.

Event Description

It was reported by the facility via their medwatch report (b)(4) that: "patient had acl repair done (b)(6) 2015.During the procedure, a guidewire was placed into the femur and the screw threaded over the wire.Once the screw was in place, the guide wire was removed.It was discovered during outpatient follow-up with subsequent films that a fragment of the guidewire, 2 mm in length, was identified.A clinical decision was made to leave the fragment in place (risk vs.Benefit).At the time of the surgery, there was nothing to suggest an issue.Later when the fragment migrated out, the patient made the decision to see another physician and the decision was made at that time to have the wire removed.The patient had surgery on (b)(6) 2016 to have the guidewire removed.It had migrated out of the bone posteriorly.The consent was worded that the patient would be having removal of painful hardware.There was no documentation to suggest the item was the fractured guidewire that would be sent to pathology.The removed piece was given to the patient post operatively.

• Brand Name: DISPOSABLE KIT, TRANS-TIBIAL ACL WITH SAW BLADE
• Type of Device: BLDE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• 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: 6394921
• MDR Text Key: 69623600
• Report Number: 1220246-2017-00061
• Device Sequence Number: 1
• Product Code: GFA
• UDI-Device Identifier: 00888867022454
• UDI-Public: 00888867022454
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: AR-1897S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR
• Patient Weight: 108