MAUDE Adverse Event Report: ORTHOFIX SRL ADV STRAIGHT CLAMP

Model Number 53530

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the axial screw code 53014 (which is the broken component of the clamp code 53530) lot v1398289 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to 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 information available on the case was sent to our medical evaluator.A preliminary medical evaluation was performed and will be finalized once further information on the event will be available.Orthofix (b)(4) has requested the distributor to provide further information on the event such as what treatment was being performed, when exactly did the screw break, copies of the pre and post operative x-rays (initial and second surgery), and device availability for the technical evaluation.Unfortunately this information has not yet been made available.As soon as further information is 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 provided by the local distributor indicates: product code: 53530 (adv straight clamp).Batch number of the axial screw code 53014: v1398289 (lot traced from combination of components during manufacturing).Qty: 1.Hospital name: (b)(6) hospital.Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2016.Date of revision surgery: (b)(6) 2016 body part to which device was applied: left femur.Surgery description: screw was broken when submitted to torque.Patient information: (b)(6), male, in good health condition.Problem observed during: clinical use on patient.Event description: screw was broken when submitted to torque.It was replace to another dispositive.The device failure had adverse effects on patient (loss of distraction/correction achieved).The initial surgery was completed with device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required following device failure (performed on (b)(6) 2016).Copies of the operative reports and copies of the x-ray images are not available.Patient current health condition: submitted for a review.On (b)(6) 2016, orthofix (b)(4) received the following additional information: patient current state of health: the patient is recovering well.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the axial screw code 53014 (which is the broken component of the clamp code 53530) lot v1398289 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: a technical evaluation of the device involved was not possible as the device has not been made available.The technical evaluation will be performed as soon as the device becomes available.Medical evaluation: the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."in this case a (b)(6) male patient was having some sort of reconstruction surgery to his femur, details not provided.An lrs advanced fixator was applied to the femur on (b)(6), and the treatment proceeded.Sometime just before (b)(6) a standard clamp locking screw broke, with loss of correction and requiring another surgery to replace the clamp.We are told that "screw was broken when submitted to torque".This implies that the screw broke after it was tightened (surgeon checking tightness of screws?).We are also told that the correction was not going well prior to the breakage.It sounds from the report as though the surgeon applied excessive torque to the locking screw.We need more information to understand what happened, such as: - what treatment was being performed? - when exactly did the screw break? - did the screw break during screw tightening? - was a torque wrench used for this? - x-rays of the case would be very helpful.Final comments: a technical evaluation of the device involved was not possible as the device has not been made available.The technical evaluation will be performed as soon as the device becomes available.A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i.E.Patient diagnosis, kind of treatment, when the screw broke, copies of the x-rays images and the device availability for the technical evaluation.Based on the lack of information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.If further information and/or the device involved becomes available, orthofix (b)(4) will finalize the investigation.Orthofix (b)(4) continues monitoring the devices on the market.Device not returned.

Event Description

The information provided by the local distributor indicates: product code: 53530 (adv straight clamp).Batch number of the axial screw code 53014: (b)(4) (lot traced from combination of components during manufacturing).Qty: 1.Hospital name: (b)(6) hospital.Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2016.Date of revision surgery: (b)(6) 2016.Body part to which device was applied: left femur.Surgery description: screw was broken when submitted to torque.Patient information: (b)(6), in good health condition.Problem observed during: clinical use on patient.Event description: screw was broken when submitted to torque.It was replace to another dispositive.The device failure had adverse effects on patient (loss of distraction/correction achieved).The initial surgery was completed with device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required following device failure (performed on (b)(6) 2016), copies of the operative reports and copies of the x-ray images are not available.Patient current health condition: submitted for a review.On august 2, 2016, orthofix (b)(4) received the following additional information: patient current state of health: the patient is recovering well.(b)(4).

Manufacturer Narrative

Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the axial screw code 53014 (which is the broken component of the clamp code 53530) lot v1398289 before the market release.No anomalies have been found.The original lot, manufactured in 2015, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation (new information): the returned clamp, received on january 9, 2017 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual, dimensional and functional check as per orthofix (b)(4) specification.The visual check evidenced presence of residuals on the clamp surface; this is most likely due to not proper decontamination activities.Moreover, it was confirmed the problem notified, the axial screw code 53014 is broken.From a verification of the breakage surface, the failure is due to torsional overload.In order to check the broken component, the clamp was disassembled.The dimensional and functional checks, performed where possible only for the broken component, did not evidence any anomalies.From the results of the technical evaluation it was concluded the device originally conformity to orthofix (b)(4) specification.The screw broke due to excessive torque.Medical evaluation (new information): the information made available on the case was sent to our medical evaluator.Please find below an extract of the medical evaluation performed."in this case a (b)(6) male patient was having some sort of reconstruction surgery to his femur, details not provided.An lrs advanced fixator was applied to the femur on (b)(6) and the treatment proceeded.Sometime just before (b)(6) a standard clamp locking screw broke, with loss of correction and requiring another surgery to replace the clamp.We are told that "screw was broken when submitted to torque." this implies that the screw broke after it was tightened (surgeon checking tightness of screws?).We are also told that the correction was not going well prior to the breakage.It sounds from the report as though the surgeon applied excessive torque to the locking screw.We need more information to understand what happened, such as: what treatment was being performed? when exactly did the screw break? did the screw break during screw tightening? was a torque wrench used for this? x-rays of the case would be very helpful." the results of the technical evaluation were sent to our medical evaluator.Please find below the last comments received."the technical analysis confirms our belief that this screw broke because of excessive applied torque.In addition the processing of the unit has been incorrect and it is possible that some corrosion may have occurred which might have weakened the screw.We must remind to follow the guidelines included in the instruction for use leaflet, ref: (b)(4).This device failed because of incorrect processing and incorrect usage." final comments: from the results of the technical evaluation it was concluded the device originally conformity to orthofix (b)(4) specification.The screw broke due to excessive torque.The medical evaluation evidenced as follow: "the technical analysis confirms our belief that this screw broke because of excessive applied torque.In addition the processing of the unit has been incorrect and it is possible that some corrosion may have occurred which might have weakened the screw.We must remind to follow the guidelines included in the instruction for use leaflet, ref: (b)(4).This device failed because of incorrect processing and incorrect usage".A complete medical evaluation of the case was not performed as some information about the medical procedure was not made available, i.E.Patient diagnosis, kind of treatment, when the screw broke, copies of the x-rays images.Based on the results of the technical evaluation and on the evidences deriving from the medical evaluation, orthofix (b)(4) can conclude that the breakage occurred was due to excessive torque applied to the screw possibly weakened by incorrect processing.Orthofix (b)(4) would like to remind that the instructions for the safe processing of the orthofix medical devices are included in the instruction for use leaflet, (b)(4).Orthofix (b)(4) continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: product code: 53530 (adv straight clamp).Batch number of the axial screw code 53014: v1398289 (lot traced from combination of components during manufacturing).Qty: 1.Hospital name: (b)(6) hospital.Surgeon name: (b)(6).Date of initial surgery: (b)(6) 2016.Date of revision surgery: (b)(6) 2016.Body part to which device was applied: left femur.Surgery description: screw was broken when submitted to torque.Patient information: (b)(6) male, in good health condition.Problem observed during: clinical use on patient.Event description: screw was broken when submitted to torque.It was replace to another dispositive.The device failure had adverse effects on patient (loss of distraction/correction achieved).The initial surgery was completed with device.The event did not lead to a clinically relevant increase in the duration of the surgical procedure.An additional surgery was required following device failure (performed on (b)(6) 2016).Copies of the operative reports and copies of the x-ray images are not available.Patient current health condition: submitted for a review.On august 2, 2016, orthofix (b)(4) received the following additional information: patient current state of health: the patient is recovering well.(b)(4).

• Brand Name: ADV STRAIGHT CLAMP
• Type of Device: ADV STRAIGHT CLAMP
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• Manufacturer Contact: roberto donadello ; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012 ; 0456719000
• MDR Report Key: 5888252
• MDR Text Key: 52491301
• Report Number: 9680825-2016-00071
• Device Sequence Number: 1
• Product Code: JDW
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 02/24/2017

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: 53530
• Device Catalogue Number: 53530
• Device Lot Number: V1398289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/25/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/10/2016; 02/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 70