MAUDE Adverse Event Report: ORTHOFIX SRL DOUBLE ROW FOOTPLATE, 180MM, TL-HEX STERILE

Model Number 99-56-22060

Device Problem Mechanical Problem (1384)

Patient Problem No Code Available (3191)

Event Date 04/28/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the device code 99-56-22060 batch v1369471 (lot laser marked on product) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4) devices.All of them have already been distributed to the market.Orthofix srl checked the internal records related to the controls made on the device code 50-10300 batch b1065233 (lot laser marked on product) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4) devices.All of them have already been distributed to the market.Technical evaluation: the devices concerned were received by orthofix srl on december 4, 2017.The technical evaluation on the returned devices is currently on going.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 the results of the investigation and/or further information are available.As soon as further information is available, orthofix srl will provide you with a follow up report.Orthofix srl continues monitoring the devices on the market.(please kindly refer also to mfr report number 9680825-2017-00074).

Event Description

The information provided by the local distributor indicates: - hospital name: (b)(6).- surgeon's name: dr.(b)(6).- date of surgery: (b)(6) 2017.- body part to which device was applied: foot.- surgery description: correction.- patient information: not provided.- problem observed during: into treatment/post-operative.- type of problem: device functional problem.- event description: it was not possible to fasten the available struts (in the loanset).Into the holes of the foot ring.Only the ultra short struts had the right fastening.These were not usable because greater gaps to the ring were needed.The surgeon connected the ring with the strut with a cable wire.The complaint report form also indicates: - the device failure had no adverse effects on patient.- the surgery was completed with the device.- the event led to a clinically relevant increase in the duration of the surgical procedure.The time for surgery increased to fix the strut in a different way.- an additional surgery was not required.- copies of the operative reports are not available.- copies of the x-ray images are not available.- patient current health condition: o.K.Note and comments: the change of the hex struts was performed with emergency tabs on the (b)(6) 2017.Manufacturer reference number:(b)(4).Distributor reference number: na.(please kindly refer also to mfr report number 9680825-2017-00074).

Manufacturer Narrative

Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 99-56-22060 batch v1369471 (lot laser marked on product) before the market release.No anomalies have been found.The original lot, manufactured in 2014, was comprised of (b)(4).All of them have already been distributed to the market.Orthofix (b)(4) checked the internal records related to the controls made on the device code 50-10300 batch b1065233 (lot laser marked on product) before the market release.No anomalies have been found.The original lot, manufactured in 2017, was comprised of (b)(4).All of them have already been distributed to the market.Technical evaluation the devices concerned were received by orthofix (b)(4) on december 4, 2017.Item medium strut tl-hex - 114mm-184mm, code 50-10300: the visual check evidenced that the device is not properly cleaned.The functional and dimensional check confirmed that the strut was originally conforming to specifications and that it still performs properly.Item double row footplate, 180mm, tl-hex sterile, code 99-56-22060: an overall investigation was performed.See details in the section -final comments- below.Medical evaluation the information made available on the case was sent to our medical evaluator.Please find below a summary of the medical evaluation performed."in this case the original surgery was performed on (b)(6) 2017, when it was found that the studs on the available struts of the correct length were not compatible with the holes in the ring, which was a double row footplate 99-56-22060.The surgeon completed the operation, providing temporary fixation between the studs and the ring with cable.4 days later the patient had an additional procedure, in which emergency tabs were applied, which allowed the surgeon to build the frame as originally intended, and start the required correction at the right time." final comments the root cause of problem notified is an incompatibility and dimensional interference between double row footplates manufactured in a limited period of the year 2014 and struts manufactured after september 2016.Orthofix (b)(4) conducted an investigation by performing technical analysis, medical evaluations and a review of the risk analysis.The result of the investigation determined that some production batches of double row footplate, manufactured in a limited period of the year 2014, are now potentially not compatible with the current version of the tl-hex struts.In detail, it is possible that the stud of the strut cannot be inserted in the hole of double row footplate.This is the reason that had brought orthofix (b)(4) to initiate a voluntary recall, reference: initial recall report 9680825-01-23-2018-001-r double row footplate tl-hex.The reported incompatibility was caused by a design problem for which the combination of tolerances of two parts (double row foot plate - struts) can generate interference with consequent difficulty to insert the stud of the strut in the hole of double row foot plate.Orthofix determined that all footplates manufactured in a specific period of year 2014 be withdrawn from the market.This problem can be detected during: - pre-planning phase without effect on patients.The pre-planning phase is recommended by orthofix (b)(4) in the instruction for use leaflet, ref.Pqtlh.- intra-operative phase, causing a prolongation of surgery time.- post-operative phase, in case of strut exchange, causing a prolongation of treatment.In any case, there are alternative procedures to complete the surgical intervention (1 - 2) and treatment (3): 1) the surgeon can use parallel external support (either footplate or ring) that do not have dimensional issues; 2) the surgeon can complete fixation temporarily using non-hexapodal truelok connection elements.This solution requires post-operative non-surgical intervention: a) - the surgeon completes the tl-hex frame with an additional parallel external support (either footplate or ring) that do not have dimensional issues; b) - the surgeon completes the frame for treatment using truelok non-hexapodal elements; 3) in case the issue arises in a strut change during treatment, the surgeon can use an emergency tab kit.Orthofix (b)(4) would like to inform you that the code reference and lot number of the double row footplate involved in this event, belong to the devices included in the initial recall report 9680825-01-23-2018-001-r double row footplate tl-hex.Orthofix (b)(4) has already introduced the following measures: inform all the distribution network and customers/users via a field safety notice in order to immediately identify the products in their warehouse which are involved in this action, remove them from inventory and return to orthofix (b)(4).With specific regard to the us market, orthofix confirms that the initial recall report 9680825-01-23-2018-001-r double row footplate tl-hex was submitted to the fda on january 24, 2018 and to the us distributor on january 25, 2018.Orthofix (b)(4) continues monitoring the devices on the market.(please kindly refer also to mfr report number 9680825-2017-00074 follow up 1).- (b)(4)].

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Date of surgery: (b)(6) 2017.Body part to which device was applied: foot.Surgery description: correction.Patient information: not provided.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.It was not possible to fasten the available struts (in the loanset) into the wholes of the foot ring.Only the ultra short struts had the right fastening.These were not usable because greater gaps to the ring were needed.The surgeon connected the ring with the strut with a cable wire.The complaint report form also indicates: the device failure had no adverse effects on patient.The surgery was completed with the device.The event led to a clinically relevant increase in the duration of the surgical procedure.The time for surgery increased to fix the strut in a different way.An additional surgery was not required.Copies of the operative reports are not available.Copies of the x-ray images are not available.Patient current health condition: o.K.Note and comments: the change of the hex struts was performed with emergency tabs on the (b)(6) 2017.Manufacturer reference number: (b)(4).Distributor reference number: na.(please kindly refer also to mfr report number 9680825-2017-00074 follow up 1).

• Brand Name: DOUBLE ROW FOOTPLATE, 180MM, TL-HEX STERILE
• Type of Device: DOUBLE ROW FOOTPLATE, 180MM, TL-HEX STERILE
• 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
• MDR Report Key: 7141505
• MDR Text Key: 95594937
• Report Number: 9680825-2017-00073
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K170650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 99-56-22060
• Device Catalogue Number: 99-56-22060
• Device Lot Number: V1369471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Removal/Correction Number: 9680825-01-23-2018-001R
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention