MAUDE Adverse Event Report: ORTHOFIX SRL GOTFRIED PC.C.P SHAFT SCREW 40MM

Model Number 183040

Device Problem Fracture (1260)

Patient Problem No Code Available (3191)

Event Date 11/03/2014

Event Type  Injury  

Event Description

The information initially provided by the local distributor indicates: hospital name - (b)(6).Surgeon name - dr.(b)(6).Date of surgery - (b)(6) 2014.Body part to which device was applied - femur.Patient information - not available.Problem observed during - clinical use on patient/intraoperative.Type of problem - device functional problem.Event description - in a short period of time, ten days, two distal screws broke ((b)(4)).Doctor says that it is very strange because he performed the surgery with the same surgical technique as always.It is the first time he had a screw broken.The complaint report form indicates: the device failure caused adverse effects to patient - un-retrieved device fragments.The surgery was completed with used device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was not required.Copies of the operative report are not available.Copies of the xrays images are not available.Information on patient current health condition: not provided.On november 28, 2014, orthofix srl received the following further information from the distributor: all the fragments of the device were removed from the patient.The screw broke during the surgery.When the breakage occurred the surgeon did not perform a re-intervention.At the moment it is not possible to collect operative reports and x-rays.The patient is fine.On december 3, 2014, the distributor confirmed to orthofix srl the following information: no adverse effects were caused to the patient.No fragments were left in the patient bone.No clinically relevant increase of the surgical procedures time occurred.The surgery was concluded using a new pccp shaft screw, immediately available.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 183034 lot lf13000840 before the market release.No anomalies have been found.The original lot, manufactured in 2013, was comprised of (b)(4) devices.All of them have already been distributed to the market.According to orthofix srl historical records, this is the first complaint notified from this specific device lot.Technical evaluation: the technical evaluation on the returned device is currently on going.Medical evaluation: the information made available on the case was sent to our medical evaluator.A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation will be available.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: GOTFRIED PC.C.P SHAFT SCREW 40MM
• Type of Device: GOTFRIED PC.C.P SHAFT SCREW 40MM
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo,verona ; IT
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni 9; bussolengo,verona ; IT
• Manufacturer Contact: via delle nazioni 9; bussolengo,verona ; 9045671900
• MDR Report Key: 4337707
• MDR Text Key: 5172277
• Report Number: 9680825-2014-00029
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K983814
• 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: 12/10/2014

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 Model Number: 183040
• Device Catalogue Number: 183040
• Device Lot Number: LF13000840
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• 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 Outcome(s): Required Intervention