MAUDE Adverse Event Report: ORTHOFIX SRL TL+ UNIVERSAL HALF PIN FIXATION BOLT 4MM - 6MM

Model Number 54-11530

Device Problem Break (1069)

Patient Problem Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Analysis of historical records: in relation to this event, orthofix received a portion of the broken bolt.The received portion did no report the batch number and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the returned portion of the broken bolt, received on december 29, 2020, is currently under technical evaluation.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 technical evaluation become available.Orthofix (b)(4) has requested further information on the event such as batch number of the device, date of the device breakage, patient current state of health and copies of the x-ray images (pre and post-operative and follow ups).Unfortunately, this information has not yet made available.As soon as the results of the investigation are available, orthofix (b)(4) will provide 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: 54-11530 (tl+ universal half pin fixation bolt 4mm - 6mm).Batch number: unknown.Quantity: 1.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: fracture treatment.Patient information: (b)(6) years, male.Problem observed during: into treatment/post-operative.Type of problem: device functional problem.Event description: tl pin fixation bolt found broken during outpatient clinic follow-up.The complaint report form also indicates: the device failure had adverse effects on patient (instability in frame).The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.A medical intervention (outpatient clinic) was required.Copies of operative reports are not available.Copies of x-ray images are not available.Product is available for return.Patient's current health condition: no response.On december 29, 2020, orthofix received the following additional details: bolt was replaced using another bolt, on (b)(6) 2020.Manufacturer reference number: (b)(4).

Manufacturer Narrative

Analysis of historical records: in relation to this event, orthofix received a portion of the broken bolt.The received portion did not report the batch number and therefore it was not possible to perform the verification of the historical data.Technical evaluation: the returned device, received on december 29, 2020, was examined by orthofix srl quality engineering department.The returned device was subjected to visual and dimensional check as per orthofix specification.The visual check confirmed the problem notified: the device is broken.The dimensional check, performed where possible, did not evidence any anomalies.A functional check was not possible as the device is broken and therefore not functioning.The device was then sent to an external laboratory for the raw material verification and failure analysis.The chemical analysis confirmed that the material composition is conforming to orthofix specifications.The technical analysis performed on the returned device shown presence of intergranular corrosion that caused breakage under load.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 40 year old male patient has been treated for a tibial fracture with truelok, the fixation being applied on feb 13th 2020.During an outpatient check recently it was noted that a screw locking bolt 54-11530 had broken.The failure required intervention.This does seem to have been a corrosive process.Possibly a cleaning agent? the widespread degradation of the metal structure is very impressive, and i do not remember seeing a failure like this before".Conclusion: the technical investigation concluded that the failure of the returned bolt is mainly attributable to intergranular corrosion, that caused breakage under load.Orthofix srl historical records show that no other similar notifications have been received in regards to this specific device code.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: product code: 54-11530 (tl+ universal half pin fixation bolt 4mm - 6mm).Batch number: unknown.Quantity: 1.Date of initial surgery: (b)(6) 2020.Body part to which device was applied: tibia.Surgery description: fracture treatment.Patient information: 40 years, male.Problem observed during: into treatment/post-operative type of problem: device functional problem.Event description: tl pin fixation bolt found broken during outpatient clinic followup.The complaint report form also indicates: the device failure had adverse effects on patient (instability in frame).The initial surgery was completed with the device.The event did not lead to a delay in the duration of the surgical procedure.A medical intervention (outpatient clinic) was required.Copies of operative reports are not available.Copies of xray images are not available.Product is available for return.Patient's current health condition: no response.On december 29, 2020, orthofix received the following additional details: bolt was replaced using another bolt, on 6th oct 2020.Further information received on february 4, 2021: 1.Date of device breakage is not known but surgeon found it on clinic day i.E 6th oct 2020.2.At the time of replacing the broken pin bolt patient's current status was fine.No adverse effect reported after the replacement.3.As per hospital protocol, they do not share x-ray images.Manufacturer reference number: (b)(4).

• Brand Name: TL+ UNIVERSAL HALF PIN FIXATION BOLT 4MM - 6MM
• Type of Device: TL+ UNIVERSAL HALF PIN FIXATION BOLT 4MM - 6MM
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 11168786
• MDR Text Key: 255899147
• Report Number: 9680825-2021-00006
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• PMA/PMN Number: K941048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54-11530
• Device Catalogue Number: 54-11530
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Date Manufacturer Received: 03/12/2021
• Patient Sequence Number: 1
• Patient Age: 40 YR