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

Model Number	B-151100
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 8, 2024, bonebridge was notified about a breakage of a leporello 3.5mm olecranon plate that occured in switzerland.The case involved a 55-year-old female patient with bilateral traumatic elbow dislocation.The patient had a highly comminuted olecranon fracture on the left side, which was treated with a leporello 3.5mm olecranon plate, and a coronoid fracture on the right side.The surgery took place on (b)(6) and was reported as uneventful.Seven weeks later, during the first postoperative visit, the x-ray revealed a plate breakage at the comminution zone.The patient reported no fall or other incident that could have caused the breakage.However, the patient reported daily household activities, inlcuding using her arm to help her husband put on support stockings.The x-rays were provided to bonebridge.Due to concerns about the fixation technique, the case was reviewed independently by two orthopedic surgeons from the bonebridge technical commission.The origin of the case was blinded to the reviewers, and they provided oral feedback to bonebridge ceo dr.(b)(6).Reviewer 1 observed that the fracture zone was not compressed and the coronoid fragment was not properly stabilized.The screws used were too short, and two long cortical screws did not secure the opposite cortical bone, leading to an unstable construct and plate failure.The reviewer suggested that significant arm movement could have contributed to the breakage as well.Reviewer 2 also noted instability in the coronoid region and the lack of compression in the comminution zone.They pointed out that this fracture should have been easy to fix, as the olecranon was intact and compression could have been achieved.The reviewer suggested that using a small mini-fragment plate might have helped.Furthermore, mechanical testing conducted by bonebridge as part of its v&v activities during development demonstrated that the bonebridge leporello 3.5mm olecranon plate implant can withstand significantly higher static and dynamic loads than the predicate device, the synthes va-lcp olecranon plate (bonebridge: 120 n at 1 million cycles; synthes: 80 n at 1 million cycles) under the same test conditions.The explant was sent to bonebridge for further investigation.The surface of the broken device revealed a typical fatigue failure, which corresponds to the inaccurate fracture repositioning and unstable construct identified by the clinical reviewers.In conclusion, the fracture was extensive and highly comminuted, and the lack of compression resulted in an unstable construct.This instability, combined with continued movement, likely caused the plate to break.Despite this outcome, the device itself is considered to have met its specifications.

• Brand Name: LEPORELLO
• Common Device Name: LEPORELLO 3.5MM OLECRANON PLATE 9 HOLE LEFT
• Manufacturer (Section D): BONEBRIDGE AG; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer (Section G): BONEBRIDGE AG; bahnhofstrasse 11; zug 6300 ; SZ 6300
• Manufacturer Contact: michelle gumpelmayer ; bahnhofstrasse 11; zug 6300 ; SZ 6300
• MDR Report Key: 20156591
• Report Number: 3021010222-2024-00002
• Device Sequence Number: 4235335
• Product Code: HRS
• UDI-Device Identifier: 07640187461954
• UDI-Public: 07640187461954
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K240318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/04/2024

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: N/A
• Device Lot Number: 220367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female