MAUDE Adverse Event Report: BONEBRIDGE AG LEPORELLO 3.5MM OLECRANON PLATE, 9 HOLE, LEFT

Model Number	B-151100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, bonebridge received a report from the (b)(6) hospital (australia) concerning a breakage of a leporello 3.5 mm olecranon plate, which occurred four weeks post-implantation.The plate had been used to stabilize a periprosthetic elbow fracture in a patient with an existing elbow prosthesis.According to the surgeon, no trauma or external event preceded the plate breakage.Revision surgery on (b)(6) 2025 confirmed plate fracture at the proximal suture holes.Radiographic images provided for investigation show that the implant had been extensively modified intraoperatively.The original 90° olecranon angle of the plate was bent into an almost flat configuration, resulting in a quasi-straight plate.This adaptation substantially altered the intended geometry and mechanical performance of the implant.Given the magnitude of deformation applied intraoperatively, a prior weakening of the plate cannot be completely ruled out.Due to the comminuted fracture pattern and the resulting long bridging span, combined with the very distal plate placement (following the shape modification), bending forces were concentrated around the suture hole.If a screw hole had been located at this position, the plate would likely have fractured at the screw-hole region due to the reduced cross-section.Furthermore, the load on the plate was amplified by the presence of the prosthesis, whose shaft terminated directly at the level of the suture hole.According to the surgical technique for the leporello 3.5 mm olecranon system, chapter "fine contouring of the plate," fine contouring is permitted to adapt the implant to the patient's anatomy: "if needed, the leporello 3.5 mm olecranon plate may be adjusted with the use of the bending irons to the anatomical situation of the patient.Warning: when bending the plate, avoid deformation of the plate holes or bending at a screw hole.Repeated bending in opposite directions may cause the device to break during postoperative treatment." in this case, radiographic analysis shows that the extent of plate bending exceeded the intended fine contouring, resulting in altered implant geometry and mechanical performance.Moreover, mechanical testing conducted during device development ("leporello tri performance test plates") demonstrated that the bonebridge leporello 3.5 mm olecranon plate withstands substantially higher static and dynamic loads than the predicate device under identical test conditions (synthes, va-lcp olecranon plate, k120070).Engineering analysis of the plate's moment of inertia identified the cross-section through the screw hole as the region of lowest bending stiffness under normal conditions.However, in the reported case, the fracture occurred at a k-wire hole, which is not typically the limiting section of the design.This indicates that the distal plate positioning and extensive intraoperative modification altered the stress distribution, shifting the highest bending load to the k-wire hole region.Based on comparative testing data, it can be concluded that a predicate device of comparable geometry would have failed earlier under identical loading conditions due to its smaller cross-section and lower fatigue strength.The investigation concludes that the plate fracture resulted from mechanical fatigue.Intraoperative straightening of the plate's original 90° contour, in combination with the presence of the prosthesis stem at the fracture site, led to increased bending stress concentrated around the suture holes, where the breakage occurred.The event is therefore attributed to altered load conditions and modified geometry, and not to a systemic device failure or product nonconformity.

• Brand Name: LEPORELLO 3.5MM OLECRANON PLATE, 9 HOLE, LEFT
• Common Device Name: LEPORELLO 3.5MM OLECRANON PLATE
• Manufacturer (Section D): BONEBRIDGE AG; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer Contact: michelle gumpelmayer ; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• MDR Report Key: 23513672
• Report Number: 3021010222-2025-00011
• Device Sequence Number: 9955566
• Product Code: HRS
• UDI-Device Identifier: 07640187461954
• UDI-Public: (01)07640187461954(17)300131(10)220367
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2025

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 Model Number: B-151100
• Device Catalogue Number: B-151100
• Device Lot Number: 220367
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male