MAUDE Adverse Event Report: ORTHOFIX SRL ELBOW HINGE

Model Number 93410

Device Problem Mechanical Problem (1384)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

Analysis of historical records orthofix srl checked the internal records related to the controls made on the (b)(4) batch b1261748 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of 11 units, (b)(4).All of them have already been distributed to the market.According to orthofix srl historical records, this is the second complaints received in regards to this specific device lot; both events occurred in the same country.Technical evaluation the device involved in this event has not yet been received by orthofix srl.Orthofix srl is strictly in contact with the local distributor to have the device concerned.The technical evaluation 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 was performed and will be finalized once the results of the investigation are available.As soon as the results of the investigation are available, orthofix srl will provide a follow up report.Orthofix srl continues monitoring the devices on the market.

Event Description

The information provided by the local distributor indicates: product code: 93410 (elbow hinge), batch number: b1261748, quantity: 1, date of initial surgery: (b)(6) 2021, surgery description:correction.Event description: the event involves one patient and one clamp.In this event, the screw fixation of the clamp broke during application.The device was immediately replaced with another clamp of same model.An additional surgery was not needed to replace the clamp.No other information will be made available on this event.Manufacturer reference number: (b)(4).

Event Description

The information provided by the local distributor indicates: - product code: (b)(4).(elbow hinge).- batch number: b1261748.- quantity: (b)(4).- date of initial surgery: (b)(6), 2021.- surgery description:correction.- event description: the event involves one patient and one clamp.In this event, the screw fixation of the clamp broke during application.The device was immediately replaced with another clamp of same model.An additional surgery was not needed to replace the clamp.No other information will be made available on this event.Manufacturer reference number: 2021087.

Manufacturer Narrative

Analysis of historical records: orthofix srl checked the internal records related to the controls made on the component code (b)(4) batch b1261748 before the market release.No anomalies have been found.The original lot, manufactured in 2018, was comprised of (b)(4) units, assembled in multiple lots of finished device code (b)(4).All of them have already been distributed to the market.According to orthofix srl historical records, this is the second complaints received in regards to this specific device lot; both events occurred in the same country.Technical evaluation: a technical evaluation of the broken device complained was not performed as the device has not been made available for the investigation.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."it does seem that the patients (complaint (b)(4) and (b)(4)) were being treated for neuropathic elbow joints.In this condition the patient cannot judge the load on the affected limb, which might explain why the components have broken.Folder (b)(4) (orthofix ref (b)(4)): this is clearly a fresh injury in a right elbow with an open wound over the proximal radius, in a 27 year old male.Again they say that 2 devices are involved but only one is shown on the images.A fracture of the proximal radius has been repaired with a plate.Again a new hinge was attached and the patient has left hospital".Conclusion: a technical evaluation of the broken device complained was not performed as the device has not been made available for the investigation.Considering the lack of information provided and the presence of discordant data, it is not possible to conduct any investigation and therefore to draw any conclusion in regards to the complained hinge breakage.Orthofix srl continues monitoring the devices on the market.

• Brand Name: ELBOW HINGE
• Type of Device: ELBOW HINGE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• MDR Report Key: 11810878
• MDR Text Key: 264842759
• Report Number: 9680825-2021-00040
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K113770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 93410
• Device Catalogue Number: 93410
• Device Lot Number: B1261748
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 79