MAUDE Adverse Event Report: ORTHOFIX SRL REDUCTION UNIT

Model Number 80047

Device Problem Device Maintenance Issue (1379)

Patient Problem No Code Available (3191)

Event Date 03/21/2014

Event Type  Injury  

Event Description

The info 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: tibia/ankle; surgery description: non union; problem occurred into treatment.Event description: reduction unit 80.047 had to be replaced 10 weeks after surgery due to movement after fixation (metal fatigue?) the complaint report form indicates: the device failure caused adverse effects to pt (loss of distraction/correction achieved).The surgery was completed with the used device.The event did not lead to a clinically relevant delay.The device was replaced after 10 weeks in outpatient clinic (no revision surgery).Copies of the operative reports and copies of the x-rays are not available.On (b)(6) 2014, orthofix srl received the following info: date of surgery: (b)(6) 2014.Remark of failure: (b)(6) 2014 (by e-mail).Device replacement: (b)(6) 2014.I honestly don't know, when the reduction unit broke down; may be it was already broken at time of surgery.(it was certainly not a new one; hospital has system on the shelf and -of course- re-use all the re-usable the system components).Pt info: male, about(b)(6) years of age, normal posture (around (b)(6), with ring fixator).Pt current health condition: pt's health is good, i.E.Normal.Vital, good sense of humor.Pt surgery was due to arthrodesis of the ankle as a result of an infectious nonunion of the distal tibial fracture after a motorbike accident.No co-morbidity.Availability of the pre-operative xrays.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 80047 (component 800073 lot b19) before the market release.No anomalies have been found.The original lot, manufactured in 2007, 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 notification received from this specific device lot.Technical evaluation: the returned device, received on (b)(4) 2014 was examined by orthofix srl quality engineering department.The device was subjected to a visual check which evidenced that it is slightly worn.The reduction unit was then disassembled in its components and subjected to dimensional and functional check.The dimensional check, performed on all components, evidenced that the two bushes are slightly under dimension.This is most likely due to the fact they are used and worn.Bushes and cams are single use devices.All other components did not evidence any dimensional anomalies.The functional check evidenced that the micrometric adjustment mechanism is not working properly.The ball joints are still working properly even if the bushes are now slightly under dimension.The results of the technical evaluation evidenced that the device was originally conforming to design specifications.The seizing of the micrometric adjustment mechanism may be due to forcing during previous uses.The medical evaluation summary and the manufacturer comments are provided.

• Brand Name: REDUCTION UNIT
• Type of Device: REDUCTION UNIT
• Manufacturer (Section D): ORTHOFIX SRL; bussolengo,verona ; IT
• Manufacturer Contact: roberto donadello, mang dir vp ; via delle nazioni 9; bussolengo,verona 37012 ; IT 37012 ; 9045671900
• MDR Report Key: 3779191
• MDR Text Key: 18731969
• Report Number: 9680825-2014-00011
• 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: 04/16/2014

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: 80047
• Device Catalogue Number: 80047
• Device Lot Number: B19
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/31/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2007
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 82