MAUDE Adverse Event Report: ARTHREX, INC. CONTOURLOCK FEMORAL OSTEOTOMY PLATE LEFT S/M; PLATE, FIXATION, BONE

Catalog Number AR-13110L-01

Device Problems Migration or Expulsion of Device (1395); Split (2537)

Patient Problem No Information (3190)

Event Date 03/26/2015

Event Type  Injury  

Event Description

It was reported that after a left osteotomy procedure, the screws were backing out of the plate and the osferion wedge split out of the bone.Follow-up investigation: patient was compliant in all post-op protocol.There is no plan for a revision to date.X-rays indicate there is a gap around the wedge in the bone.

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.The device was requested for evaluation but part remains in the patient and cannot be returned; therefore, the complainant's event could not be verified.Device history record review revealed nothing relevant to this event.The contribution of the arthrex device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.If the device is returned and additional information is obtained, a follow-up report will be submitted.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.Part remained in patient.

• Brand Name: CONTOURLOCK FEMORAL OSTEOTOMY PLATE LEFT S/M
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4722349
• MDR Text Key: 5737836
• Report Number: 1220246-2015-00103
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Catalogue Number: AR-13110L-01
• Device Lot Number: 1142469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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
• Treatment: AR-13280-35, CANCELLOUS SCREW, LOT 118582; AR-13280-50, CANCELLOUS SCREW, LOT J573040; AR-13370-1, OSFERION OSTEO WEDGE, LOT M14309B402; AR-13380-52, CORTICAL SCREW, LOT 1188700; AR-13380-42, CORTICAL SCREW, LOT 1188670; AR-8545L-45, LOW PROFILE SCREW, LOT UNKNOWN.; AR-13380-46, CORTICAL SCREW, LOT 1188683; AR-13380-44, CORTICAL SCREW, LOT 1188674.; AR-13280-50, CANCELLOUS SCREW, LOT 1188602; AR-13333, OSTEOTOMY JACK, LOT UNKNOWN.
• Patient Outcome(s): Other