MAUDE Adverse Event Report: ORTHOFIX SRL LRS MULTIPLANAR CLAMP

Model Number 50580

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix (b)(4) is verifying the lot number of item 50580, communicated by the local distributor (lot v1556221 or lot b73).As soon as the lot is identified, the verification of the historical data will be performed.Technical evaluation: the device involved in this event has not yet been received by orthofix (b)(4).Orthofix (b)(4) is strictly in contact with the local distributor to have the device concerned.The technical evaluation of the device involved will be performed as soon as the device become available.Medical evaluation: the information provided on the event was sent to our medical evaluator.A preliminary medical evaluation is currently on going and will be finalized once further information and/or the results of the technical evaluation are available.As soon as further information are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information originally provided by the local distributor on may 9, 2016 indicates: an lrs multiplanner new clamp was fixed to patient on (b)(6).Patient came back to hospital on (b)(6) 2016 for check up where surgeon found pin came out.The distributor attached to the notification, pictures of the event notified -pin coming off the clamp.On june 7, 2016, orthofix (b)(4) received from the distributor the completed complaint form reporting the following information: hospital name: (b)(6); surgeon name: dr.(b)(6); date of initial surgery: (b)(6) 2016; body part to which device was applied : left femur; surgery description: lengthening / correction; patient information: (b)(6), male, weight (b)(6), height (b)(6); previous health conditions: not known; problem observed during: into treatment/post-operative; type of problem: device functional problem -device failure; event description: after 10 days hinge pin came out.Surgeon managed to push back but again came out.Surgeon tried to hold with other u-clamp till replacement of multiplanar was done with another new one.Surgery was performed without any problem.Hinge pin of multiplanar came out after 10 days from surgery.The complaint report form also indicates: the device failure had adverse effects on patient -loss of fracture reduction; loss of distraction/correction achieved; the surgery was completed with used device; an additional surgery was required -(b)(6) 2016; copies of the operative reports are not available; copies of the xrays images are available; information on patient current health condition: after replacement of multiplanar so far no complaint reported.Condition is normal.Note: "based on our documents, lot number recorded from box of multiplaner was v1556221, other number stated on clamp is b73." (b)(4).

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 50580, lot b73 (lot laser marked on the component 500581), before the market release.No anomalies have been found.The original lot, manufactured in 2012, 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 june 17, 2016 was examined by orthofix srl quality engineering department.The device was subjected to visual and dimensional check as per orthofix srl design and product specifications.The visual check evidenced that the device was returned correctly assembled.Probably the pin was reinserted by the end user.Some scratches due to normal wear and tear were noticed on the external surfaces, but no major damages could be observed.The dimensional check confirmed that the device was originally conforming to design specifications.The functional check confirmed that all movements of correction and translation could be correctly performed.After the functional check, the device was dismantled in order to check the single components.It was necessary to use a hammer and a vice to make the pin come out, meaning it was well inserted in the device's body.Orthofix failure analysis concluded that it is not possible to determine a root cause of the device failure with the information provided.The pin may have come out as a result of a load applied on the axis of the pin.The application issues should be investigated to detect the cause of this event.Medical evaluation the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation: " i note that this is the first complaint for 5 years of this device.In this case a (b)(6) man had a hypertrophic non-union of the left femur mid shaft, which is being treated with the lrs system including a multiplanar clamp.It seems that this patient has been treated very well, and the scan shows that the deformity has been fully corrected, with a normal limb axis.All we know is that the hinge pin of this device came loose, and the device was replaced after 10 days.This event was treated excellently and the patient is doing very well.The very carefully reported technical analysis does not give us a clear reason as to why the pin of this multiplanar clamp came out.The pin and the seating hole are within manufacturing tolerances.Therefore, we must conclude that there must have been very special circumstances relating to the application that caused this event." final comments the results of the dimensional and functional check confirmed that the device was originally conforming to design specifications.Orthofix failure analysis could not determine a root cause of the failure.The pin may have come out as a result of a load applied on the axis of the pin.The application issues should be investigated to detect the cause of this event.The medical evaluation evidenced as follow: "the pin and the seating hole are within manufacturing tolerances.Therefore, we must conclude that there must have been very special circumstances relating to the application that caused this event." orthofix srl historical records shows that no other similar notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.

Event Description

The information originally provided by the local distributor on (b)(6) 2016 indicates: an lrs multiplanner new clamp was fixed to patient on (b)(6).Patient came back to hospital on (b)(6) 2016 for check up where surgeon found pin came out.The distributor attached to the notification, pictures of the event notified -pin coming off the clamp.On (b)(6) 2016, orthofix srl received from the distributor the completed complaint form reporting the following information: o hospital name: (b)(6) hospital - (b)(6); o surgeon name: dr.(b)(6); o date of initial surgery: (b)(6) 2016; o body part to which device was applied : left femur; o surgery description: lengthening / correction; o patient information: (b)(6), male, (b)(6); previous health conditions: not known; o problem observed during: into treatment/post-operative; o type of problem: device functional problem -device failure; o event description: after 10 days hinge pin came out.Surgeon managed to push back but again came out.Surgeon tried to hold with other u-clamp till replacement of multiplanar was done with another new one.Surgery was performed without any problem.Hinge pin of multiplanar came out after 10 days from surgery.The complaint report form also indicates: o the device failure had adverse effects on patient -loss of fracture reduction; loss of distraction/correction achieved; o the surgery was completed with used device; o an additional surgery was required -(b)(6) 2016; o copies of the operative reports are not available; o copies of the xrays images are available; o information on patient current health condition: after replacement of multiplanar so far no complaint reported.Condition is normal.Note: "based on our documents, lot number recorded from box of multiplaner was (b)(4), other number stated on clamp is b73." manufacturer reference number: (b)(4).

• Brand Name: LRS MULTIPLANAR CLAMP
• Type of Device: LRS MULTIPLANAR CLAMP
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012 ; 0456719000
• MDR Report Key: 5702909
• MDR Text Key: 46687347
• Report Number: 9680825-2016-00049
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K955848
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

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: 50580
• Device Catalogue Number: 50580
• Device Lot Number: B73
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2012
• 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
• Patient Age: 25 YR
• Patient Weight: 65