MAUDE Adverse Event Report: ORTHOFIX SRL GOTFRIED PCCP SHAFT SCREW - 40 MM "PACK OF 5"; GOTFRIED PC.C.P. SHAFT SCREW 40MM

Model Number 183540

Device Problem Fracture (1260)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2015

Event Type  malfunction  

Event Description

The information provided by the local distributor indicates: hospital name: hospital (b)(6); surgeon name: dr.(b)(6); date of surgery: (b)(6) 2015; body part to which device was applied: hip; surgery description: fracture treatment; patient information: (b)(6); problem observed during: clinical use on patient / intraoperative; event description: "during the manual screwing, the pccp shaft screw 40 mm broke, a portion seems to be left in the patient bone." the complaint report form indicates: no adverse effects to patient; 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 x-ray images are not available; information about patient current health condition: "the patient is in good health condition, performs hip movements with little limitation." (b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code (b)(6) lot v1384153 before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) screws.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint notified from this specific device lot.Technical evaluation: the technical evaluation of the device involved will be performed as soon as the device becomes available.Medical evaluation: the little 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 becomes available.Orthofix (b)(4) has requested further information on the event such as confirmation that a portion of the device was left in the patient bone, copies of the operative report, copies of the x-ray images and the device availability for the technical evaluation.Unfortunately, this information has not yet made available.As soon as further information will be available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.

• Brand Name: GOTFRIED PCCP SHAFT SCREW - 40 MM "PACK OF 5"
• Type of Device: GOTFRIED PC.C.P. SHAFT SCREW 40MM
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo, verona ; IT
• Manufacturer Contact: roberto donadello, managing direc ; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 4616419
• MDR Text Key: 5591316
• Report Number: 9680825-2015-00007
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: CI
• 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: 03/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 183540
• Device Catalogue Number: 183540
• Device Lot Number: V1384153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2015
• Initial Date FDA Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 89 YR
• Patient Weight: 65