MAUDE Adverse Event Report: ORTHOFIX SRL TL,BOLT, WIRE FIXATION, UNIVERSAL

Model Number 54-1152

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the device code 54-1152 lot af1681 before the market release.No anomalies have been found.The original lot, manufactured in 2019, was comprised of 1155 devices.All of them have already been distributed to the market.According to orthofix srl historical records, no other notifications have been received in regards to this specific device lot.Technical evaluation: the returned device, received on july 22, 2020, was examined by orthofix srl quality engineering department.The device was subjected to visual, dimensional and functional check as per orthofix specifications.The visual check confirmed that the threaded rod is broken due to torsional overload.The dimensional check of the threaded portion of the bolt, performed using the threaded gauge sc400, confirmed that it was originally conforming to orthofix specifications.The functional check, performed using the returned nut, confirmed that the threaded portion of the bolt is functioning properly with m6 x 1 hex nut.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 evaluation performed."this tl bolt broke within 2 days of being applied, so there must have been something distinctive about the first application.They do not tell us the location of the bolt that broke.The pictures tell us little more.From the technical report, i note that the bolt shows clear signs of excessive torque which caused partial failure at the time of application.As a result of this the bolt failed under the normal clinical load.I agree with the technical report that the bolt failed because of excessive load".Conclusion: the results of the technical investigation confirmed that the returned bolt was originally conforming to orthofix specifications.The breakage occurred is most likely attributable to the application of an excessive torque to lock the device to the ring.Orthofix historical records show that no other notifications have been received in regards to this specific device lot.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: hospital name: (b)(6).Surgeon name: dr (b)(6).Date of initial surgery: (b)(6) 2020.Body part to which device was applied: tibia.Surgery description: other, see event description.Patient information: male, (b)(6)kg, with infection.Problem observed during: other, see event description.Type of problem: device functional problem.Event description: "the surgery was done because the patient had a plate placed on a fracture which got infected.The surgery went well.While the patient was asleep in his bed, one of the bolt of the truelok broke.Patient will be reoperated to strengthen the construct again on (b)(6) 2020".The complaint report form also indicates: the device failure had adverse effects on patient (loss of achieved correction).The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.An additional surgery was required: scheduled on (b)(6) 2020.Copies of the operative reports are not available.Copies of the x-rays images are not available.Product is available for return.The event should be notified to the local competent authority.Information about patient current health condition is not available.On july 16, 2020, orthofix srl received the following further information, together with an x-ray and two pictures: "the patient was fine, no health issues related to the product.He is being reoperated today, so hopefully we will get some information tomorrow".Further information received on july 17, 2020: "for your information, the patient was supposed to have the revision surgery today, but it has been postponed to monday".Further information received on july 21, 2020: "the patient was reoperated yesterday in order to correct the broken bolt.From the surgeon's feedback, the operation went well and the patient is fine".Manufacturer reference number: (b)(4).

• Brand Name: TL,BOLT, WIRE FIXATION, UNIVERSAL
• Type of Device: TL,BOLT, WIRE FIXATION, UNIVERSAL
• 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: 10390699
• MDR Text Key: 208126660
• Report Number: 9680825-2020-00044
• Device Sequence Number: 1
• Product Code: LXT
• UDI-Device Identifier: 18033509853760
• UDI-Public: (01)18033509853760(11)191025(10)AF1681
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K941048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2020

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: 54-1152
• Device Catalogue Number: 54-1152
• Device Lot Number: AF1681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80