MAUDE Adverse Event Report: ORTHOFIX SRL SHORT STRUT TL-HEX -92MM-122MM

Model Number	50-10200
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis of historical records: orthofix (b)(4) checked the internal records related to the controls made on the device code 50-10200 batch v1350868 (lot marked on the component: v1339795) before the market release.No anomalies have been found.The lot v1339795, manufactured in 2013, was comprised of (b)(4) struts.All of them have already been distributed to the market.According to orthofix (b)(4) historical records, this is the first complaint received in regards to this specific device lot.Technical evaluation: the returned strut, received on january 3, 2018 was examined by orthofix (b)(4) quality engineering department.The returned device was subjected to visual and dimensional check as per orthofix (b)(4) specification.The visual check evidenced strong presence of damaging (device discoloration).The dimensional check, performed where possible, did not evidence any anomalies.It was not possible to perform the functional test, as one component (insert bushing) is missing.The results of the technical investigation evidenced that the returned parts of the device were originally conforming to specification.Since the insert bushing is missing, it was not possible to finalize the investigation and determine the root cause of the event notified.Medical evaluation: the information made available on the case together with the results of the technical evaluation were sent to our medical evaluator.Please find below an extract of the medical evaluations performed."in this case a female patient, a child as it is at a children's hospital, had a frame applied about 12 months ago, for lengthening of the tibia.The parents were still making corrections, and the black knob became separated making the strut non functional.This caused great anxiety for the parents, but the strut was changed quickly and the lengthening continued and finished as planned.I can understand the anxiety; this family had been correcting the tibia and keeping the child happy for nearly 12 months, when a fixator component seems to fail and possibly the correction is lost (the parents think).Of course they are worried, but as it happens they contacted the surgeon quickly and the strut was replaced, with no harm done.We know nothing beyond these facts.The patient has come to no harm.Lengthening of a bone requires constant supervision and adjustment, so failure of a component should be picked up very early and managed as here by immediate replacement.This is a very rare event, so either there is something particular with this batch of devices, or something related to the technique used".January 15, 2018 with the further information provided."the original frame was applied at the beginning of the year and the failure occurred "some time in the summer".The time scale now fits for a tibial lengthening.The surgeon cannot remember the name of the patient, so the whole complaint is based on an imperfect memory and recording system.It is difficult to make any specific comments when these details are not known.No alteration in the conclusions about this case".Final comments: the results of the technical investigation evidenced that the returned parts of the device were originally conforming to specification.Since the insert bushing is missing, it was not possible to finalize the investigation and determine the root cause of the event notified.The medical evaluation evidenced as follow: "in this case, a female patient, a child as it is at a children's hospital, had a frame applied about 12 months ago, for lengthening of the tibia.The parents were still making corrections, and the black knob became separated making the strut non functional.This caused great anxiety for the parents, but the strut was changed quickly and the lengthening continued and finished as planned.I can understand the anxiety; this family had been correcting the tibia and keeping the child happy for nearly 12 months, when a fixator component seems to fail and possibly the correction is lost (the parents think).Of course they are worried, but as it happens they contacted the surgeon quickly and the strut was replaced, with no harm done.We know nothing beyond these facts.The patient has come to no harm.Lengthening of a bone requires constant supervision and adjustment, so failure of a component should be picked up very early and managed as here by immediate replacement.This is a very rare event, so either there is something particular with this batch of devices, or something related to the technique used".January 15, 2018 with the further information provided."the original frame was applied at the beginning of the year and the failure occurred "some time in the summer".The time scale now fits for a tibial lengthening.The surgeon cannot remember the name of the patient, so the whole complaint is based on an imperfect memory and recording system.It is difficult to make any specific comments when these details are not known.No alteration in the conclusions about this case".Based on the information available on the event, it was not possible to finalize the investigation and determine the root cause of the event notified.Orthofix (b)(4) historical records shows that no other similar notifications have been received in regards to this specific device lot.Orthofix (b)(4) continues monitoring the devices on the market.- attachment: [2018002_fda medwatch cover letter.Pdf].
Event or Problem Description
The information initially provided by the local distributor indicates: hospital name: (b)(6).Surgeon's name: (b)(6).Date of surgery: unknown, beginning of the year 2017.Body part to which device was applied: tibia.Surgery description: lengthening.Patient information: female.Problem observed during: into treatment/post-operative.Type of problem: no response.Event description: "during treatment the black part of the strut, located at the back of the mouthpiece, on each side of the strut, left.It took off alone.The parents when (scared) as soon they could to change the strut.The black piece was gone.Result of it: the strut was not functional and they had to change for a new one.The patient had to stop the correction for few days (that was almost the end).After the change of the strut, the frame was ok.The correction end properly".The complaint report form also indicates: the device failure had adverse effects on patient [change the strut and being very scared (for the parent) of the instability of the frame]; copies of the operative reports are not available; copies of the x-ray images are not available; patient current health condition: good.On january 15, 2018, orthofix (b)(4) received the following additional information from the local distributor: the device failed during the summer.The strut was replaced at the doctor's office (outpatient clinic).Copies of the operative report and copies of the pre and post-operative x-rays are not available.No problems occurred during the initial surgery.Manufacturer reference number: 2018002.(b)(4).

• Brand Name: SHORT STRUT TL-HEX -92MM-122MM
• Common Device Name: SHORT STRUT TL-HEX -92MM-122MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, italy 37012 ; IT 37012
• MDR Report Key: 7233431
• Report Number: 9680825-2018-00006
• Device Sequence Number: 13951797
• Product Code: KTT
• UDI-Device Identifier: 18054242510635
• UDI-Public: (01)18054242510635(11)131001(10)V1350868
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K170650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

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
• Operator of Device: Health Professional
• Device Model Number: 50-10200
• Device Catalogue Number: 50-10200
• Device Lot Number: V1350868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention