MAUDE Adverse Event Report: ORTHOFIX SRL 160 MM DOUBLE ROW FOOT PLATE

Model Number 56-13635

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Type  malfunction  

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon name: (b)(6).Date of surgery: (b)(6) 2014.Surgery description: correction -stabilization of post traumatic deformity in the left ankle.Problem observed during: into treatment.Event description: during treatment on patient the double row foot plate broke in the medial section.The complaint report form indicates: the surgery was completed with used device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.Copies of the operative reports are not available.Copies of the x-rays images are not available.Information on patient current health condition: the patient is suffering from pain in loading the limb, which forces him to stay in bed.Manufacturer ref.(b)(4).

Manufacturer Narrative

Analysis of historical records: the device is still in use by patient.No information about lot involved in available, therefore it is not possible to perform any analysis of historical records.According to orthofix srl historical records, this is the first notification received from this specific device code.Technical evaluation: a technical evaluation of the broken device used was not performed as the device is still in use by patient.The technical evaluation will be performed as soon as the device becomes available.Medical evaluation: the information made available on the case was sent to our medical evaluator.The medical evaluation is currently ongoing and will be closed once further information on the case will be available.Orthofix srl has requested further information on the event such as patient's effects, copy of the pre and post-operative x-rays, copy of operative report, date of device breakage.As soon as further information will be available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.

• Brand Name: 160 MM DOUBLE ROW FOOT PLATE
• Type of Device: 160 MM DOUBLE ROW FOOT PLATE
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo, verona ; IT
• Manufacturer Contact: roberto donadello, vp ; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 4364992
• MDR Text Key: 5111294
• Report Number: 9680825-2014-00031
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K941048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 56-13635
• Device Catalogue Number: 56-13635
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2014
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR