MAUDE Adverse Event Report: ORTHOFIX SRL GALAXY UNYCO MINI KIT INSTRUMENTS STERILE

Model Number	99-93509
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2017
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 99-93509 lot v1427350 (component code 93568s, lot 8056) before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been distributed to the market.Technical evaluation: the involved device has not been returned yet to orthofix (b)(4).The technical evaluation of the device involved 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.A preliminary medical evaluation is currently on going and will be finalized once the results of the technical evaluation and/or further information on the case are available.As soon as further information and/or the results of the technical evaluation are available, orthofix (b)(4) will provide you with a follow up report.Orthofix (b)(4) continues monitoring the devices on the market.
Event or Problem Description
Event occurred during post-market clinical study (ref: (b)(6)) the information provided by the local distributor indicates: hospital name: clinic (b)(6); surgeon name: dr.(b)(6); date of surgery: (b)(6) 2017; body part to which device was applied: tibia; surgery description: non union; patient's information: not available; previous health condition: healthy; problem observed during: clinical use on patient; type of problem: device functional problem; event description: breakage of torque limiter during insertion with power drill.Easy solution: opened a new one.The complaint form also indicates: the device failure did not have any adverse effects on patient; the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was not required; copies of the operative report are not available; copies of x-ray images are not available; information on patient current health condition: ok, no pain/problems.Note and comments: recovered during replenishment -no surgery involved.Increased surgery time about 5 min due to exchange to a new torque limiter.(b)(4).
Additional Manufacturer Narrative
Analysis of historical records orthofix (b)(4) checked the internal records related to the controls made on the device code 99-93509 lot v1427350 (component code 93568s, lot 8056) before the market release.No anomalies have been found.The original lot, manufactured in 2016, was comprised of (b)(4) devices.All of them have already been distributed to the market.Technical evaluation the returned device, received on april 3, 2017 was examined by orthofix (b)(4) quality engineering department.The device was subjected to visual check as per orthofix (b)(4) design and product specifications.The visual check confirmed that the device is broken in two parts.The mould of the device seems correct.There is no evidence of cold joints and the thickness of the fracture area seems equable.The welding between part "a" and part "b" seems not continuous.It was not possible to perform the functional check as the device is broken.The technical analysis performed evidenced that the returned device was not originally conforming to specifications.The breakage that occurred was identified in a welding process error due to a manufacturing problem.Medical evaluation: the information made available on the case together with the results of the technical investigation, was sent to our medical evaluator.Please find below an extract of the medical evaluation: "in this case a unyco frame was being applied to a tibia in a patient with a non-union.At some stage during the application the torque limiter broke, as shown in the picture of the broken device.It was replaced immediately and the operation continued to completion.We do not know how many screws were inserted and during which of these the device broke.It would be good to know this.The surgeon could have inserted the screw without the limiter, but in theory this is not such a good technique.Additional medical evaluation based on the results of the technical analysis: "this technical analysis makes it clear that the welding to join parts a and b on this device was incomplete.You will be pursuing the cause of this with the manufacturer." final comments the technical analysis performed evidenced that the returned device was not originally conforming to specifications.The breakage that occurred was identified in a welding process error due to a manufacturing problem.Based on the results of the technical evaluation performed on the returned device, that evidenced its non-conformity to orthofix (b)(4) specifications, as a remedial action, orthofix (b)(4) engaged the supplier that is currently undertaking the following actions to prevent the recurrence of the non-conformity: -design improvement and manufacturing process improvement of the device.Orthofix (b)(4) performed a risk assessment on the event.The level of severity associated with the failure mode is moderate and the overall risk is below the acceptability threshold.The results of the risk analysis verification do not evidence the necessity to implement any other means of risk mitigation.Orthofix (b)(4) continues monitoring the devices on the market.
Event or Problem Description
Event occurred during post-market clinical study ((b)(6)) the information provided by the local distributor indicates: hospital name: clinic (b)(6); surgeon name: dr.(b)(6); date of surgery: (b)(6) 2017; body part to which device was applied: tibia; surgery description: non union; patient's information: not available; previous health condition: healthy; problem observed during: clinical use on patient; type of problem: device functional problem; event description: breakage of torque limiter during insertion with power drill.Easy solution: opened a new one.The complaint form also indicates: the device failure did not have any adverse effects on patient; the surgery was not completed with used device; a replacement device was immediately available to complete surgery; the event did not lead to a clinically relevant increase in the duration of the surgical procedure; an additional surgery was not required; copies of the operative report are not available; copies of x-ray images are not available; information on patient current health condition: ok, no pain/problems.Note and comments: recovered during replenishment - no surgery involved.Increased surgery time about 5 min due to exchange to a new torque limiter.(b)(4).

• Brand Name: GALAXY UNYCO MINI KIT INSTRUMENTS STERILE
• Common Device Name: GALAXY UNYCO MINI KIT INSTRUMENTS STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 6459691
• Report Number: 9680825-2017-00013
• Device Sequence Number: 590977
• Product Code: KTT
• UDI-Device Identifier: 18054242513629
• UDI-Public: (01)18054242513629(10)V1427350(11)160509(17)210409
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K153233
• 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,Followup
• Report Date (Section B): 05/10/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/09/2021
• Device Model Number: 99-93509
• Device Catalogue Number: 99-93509
• Device Lot Number: V1427350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/05/2017
• Supplement Report FDA Received Date: 05/11/2017
• 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