MAUDE Adverse Event Report: BONEBRIDGE AG LORRAINE; LORRAINE 3.5MM MEDIAL DISTAL HUMERUS PLATE, 6 HOLE

Model Number	LORRAINE 3.5MM DISTAL HUM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon attributes the complication to the complexity of the four-part fracture and persistent micromovements during the healing process, which resulted in repeated mechanical stress on the fixation.
Event or Problem Description
On (b)(6) 2025, dr.(b)(6) reported screw breakage and loosening in a patient treated with lorraine medial and posterolateral distal humerus plates.The issue occurred only on the medial plate.The initial surgery took place on (b)(6) 2025.The patient is a 58-year-old male (180 cm, 80 kg) with no known comorbidities or smoking history.He sustained a complex open ao 13c fracture as part of a polytrauma.Surgical fixation was performed using medial and posterolateral lorraine plates without intraoperative complications.At 6 weeks postoperative, healing was considered to be progressing normally; however, radiographs showed visible fracture lines with no consolidation.At 12 weeks ((b)(6) 2025), one screw on the medial plate was found broken, with loosening of two additional screws medially and one laterally.New bone tissue has formed on the outer surface of the shaft (diaphysis), within the periosteum, and medially in the periarticular region.However, the fracture gaps in the near the joint (intra-articular) and at the end of the bone (metaphyseal region) remained clearly visible, indicating delayed bone union.The surgeon attributed the complication to micromovements at the fracture site due to the complexity of the 4-part fracture and high mechanical stress, despite using multiple screws.The surgeon considers this mechanical overload, combined with the complexity of the fracture, to be a plausible cause of the observed complication.Furthermore, as this was a polytrauma case and the patient had also suffered a pelvic fracture, he was mobilised with crutches 6-8 weeks after the operation.The surgeon stated that this mobilization was permitted in clinical context as at the six-week follow-up, the healing process was considered normal.Hence, mobilisation commenced during a period when bone healing was ongoing but incomplete.Nevertheless, early weight-bearing with crutches, although permitted by the surgeon, may have increased the mechanical load on the construct, contributing to the observed screw breakage and loosening.This permitted weight-bearing is therefore considered an additional plausible factor in explaining the complication, alongside the challenging biomechanical conditions and fracture complexity.Based on the available information, it is concluded that the complication was caused by ongoing micromovements at the fracture site, which subjected the screws to repeated mechanical stress.This resulted in the screws gradually loosening and screw breakage.There is no evidence of device failure as confirmed by the surgeon.The device met its specifications and functioned as intended.Therefore, the complication is attributed to a combination of challenging biomechanical conditions of the fracture and early mobilization with crutches.A device-related failure is excluded.

• Brand Name: LORRAINE
• Common Device Name: LORRAINE 3.5MM MEDIAL DISTAL HUMERUS PLATE, 6 HOLE
• Manufacturer (Section D): BONEBRIDGE AG; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer (Section G): BONEBRIDGE AG; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• Manufacturer Contact: salome brütsch ; bahnhofstrasse 11; zug, 6300 ; SZ 6300
• MDR Report Key: 22565402
• Report Number: 3021010222-2025-00003
• Device Sequence Number: 9348104
• Product Code: HRS
• UDI-Device Identifier: 07640187462067
• UDI-Public: 07640187462067
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K231292
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/22/2025

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: LORRAINE 3.5MM DISTAL HUM
• Device Catalogue Number: B-160100
• Device Lot Number: 400212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• 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: Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG