MAUDE Adverse Event Report: ORTHOFIX SRL EIGHT PLATE SCREW 32MM STERILE

Catalog Number	99-GP432CE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device involved in this event has not been returned for investigation, but it has been requested to return.If the device is returned an investigation will be completed and a follow up report will be submitted.
Event or Problem Description
It was reported that a 8-plate screw broke during the removal surgery.A portion of the screw was left in patient's bone.
Event or Problem Description
It was reported that a 8-plate screw broke during the removal surgery.A portion of the screw was left in patient's bone.
Additional Manufacturer Narrative
Orthofix checked the internal records related to the controls made on the device code 99-gp432ce, lot: b1749914 before the market release.No anomalies have been found.The original lot, manufactured in 2021, was comprised of (b)(4) units.All of them have already been distributed to the market.According to orthofix historical records, no other breakages have been received regarding this specific device lot.A technical evaluation of the device involved was not possible, as the device was not returned.The technical evaluation will be performed should the device become available.Orthofix would like to remind that the information about the implant removal is included in the related instruction for use, re.Pqggp.An extract is reported below."notes for use - implant removal: the implants should be removed at conclusion of treatment, but anyway before the screws reach their maximum angle.Patients must be closely followed since achievement of the desired correction may require plate removal as early as 3 to 12 months after insertion.Hcp should consider premature removal in case of adverse events".Orthofix would like to also remind that the information about the screw selection (solid screws or cannulated screws) is included in the related operative technique, re.Ep-1107-opt.An extract is reported below."note: select the appropriate screw, length and type (solid or cannulated) according to patient's anatomy, physis thickness and desired correction to be achieved.When selecting the screws, the following criteria should be considered: make sure the screw's length will be contained within the epiphysis and the metaphysis (avoid to penetrating the opposite cortex) solid screws are more resistant to breakage than cannulated screws, and this should be taken into consideration when treating heavy patients or when planning a long treatment time".Should further information and/or the devices involved are received, orthofix will promptly re-open the investigation on the case.

• Brand Name: EIGHT PLATE SCREW 32MM STERILE
• Common Device Name: EIGHT PLATE SCREW 32MM STERILE
• Manufacturer (Section D): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer (Section G): ORTHOFIX SRL; via delle nazioni, 9; bussolengo, verona, 37012 ; IT 37012
• Manufacturer Contact: elvira taccarelli ; via delle nazioni, 9; bussolengo, verona 37012 ; IT 37012
• MDR Report Key: 22802644
• Report Number: 9680825-2025-00030
• Device Sequence Number: 12963053
• Product Code: HRS
• UDI-Device Identifier: 18033509852664
• UDI-Public: 18033509852664
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K031493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2026
• Device Catalogue Number: 99-GP432CE
• Device Lot Number: B1749914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown