MAUDE Adverse Event Report: ORTHOFIX SRL WIRE TENSIONER

Model Number 18001

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Code Available (3191)

Event Date 05/11/2014

Event Type  Injury  

Event Description

The info provided by the local distributor indicates: hospital name: (b)(6); surgeon name: (b)(6); date of surgery: (b)(6) 2014; problem observed during: clinical use on pt/ intraoperative.Event description: it's not possible to tighten k-wires.K-wires slip through the device.The complaint report form indicates: the surgery was not completed with the device.A replacement device was not immediately available to complete the surgery (loan device from pmm was used the day after).On (b)(6) 2014, orthofix srl received the following add'l info on the event: the device malfunctioned during the surgery ((b)(6) 2014).As a replacement device was not immediately available, the surgery was abandoned and postponed to the day after (date of revision surgery (b)(6) 2014).Apart of the re-intervention, no adverse effects occurred (so far).No other info has been made available.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 180001s lot b183 before the market release.No anomalies have been found.The original lot, manufactured in 2010, was comprised of 1 device which was assembled in the finished device code 18001 lot it974213 comprised of (b)(4) wire tensioners.According to orthofix (b)(4) historical records, no other notifications have been received in regards to the code 18001 lot it974213.Technical eval: the returned device, received on (b)(6) 2014, was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual and functional check as per orthofix (b)(4) design and product specs.The visual check did not evidence any anomalies.The functional check, performed using an internal specific instrumentation, evidenced that the returned device can function as intended.The results of the technical eval evidenced that the returned device still performs properly.The problem notified may be attributed to organic residuals occluding the cannulation.Medical eval: the info available on the case was sent to our medical evaluator.A preliminary medical eval was performed and will be finalized once further info on the event is available.Mfr's comments: orthofix has requested further info on the event to finalize the medical eval such as pt info (age, sex, weight and diagnosis), copies of the operative reports (initial surgery and revision one), copies of the pre and post-operative x-rays (initial surgery and revision one), picture of the frame application and info on pt current health condition.Unfortunately, this info has not yet made available.As soon as further info is available, orthofix (b)(4) will provide you with a f/u report.Orthofix (b)(4) continues monitoring the devices on the market.

• Brand Name: WIRE TENSIONER
• Type of Device: WIRE TENSIONER
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo, verona ; IT
• Manufacturer Contact: roberto donadello, managing dir., ; via delle nazioni 9; bussolengo, verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 3908045
• MDR Text Key: 4588516
• Report Number: 9680825-2014-00016
• Device Sequence Number: 1
• Product Code: JEC
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K944092
• 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: 06/12/2014

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: 18001
• Device Catalogue Number: 18001
• Device Lot Number: B183
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 06/13/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention