MAUDE Adverse Event Report: MERETE GMBH OSTEOBRIDGE¿ IDSF SYSTEM; INTRAMEDULLARY FIXATION SYSTEM,

Model Number	GB70009S
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During a surgery a mislabeled osteobridge idsf femoral nail has been identified.The surgeon wanted to implant a femoral idsf system.After cemented implantation of the nails he recognized that the clamping diameter of one nail was 14 mm instead of 16 mm (femoral idsf nails have 16 mm).This led tot he circumstance that the spacer which shall connect the nails did not fit.Therefore the surgeon therefore decided to use a temporary implant around 14mm clamping area of nail to protect nail end.An idsf spacer provisionally clamped onto construct to manage length of extremity.Patient/ surgeon have been be provided with a custom made device for final surgery.

• Brand Name: OSTEOBRIDGE¿ IDSF SYSTEM
• Common Device Name: INTRAMEDULLARY FIXATION SYSTEM,
• Manufacturer (Section D): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12249 , DE; GM 12249, DEU
• MDR Report Key: 14274375
• Report Number: 3012147813-2022-00001
• Device Sequence Number: 14662780
• Product Code: HSB
• UDI-Device Identifier: 04048266179623
• UDI-Public: (01)04048266179623(17)250604(10)MS1811663R
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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
• Device Expiration Date: 06/04/2025
• Device Model Number: GB70009S
• Device Catalogue Number: GB70009S
• Device Lot Number: MS1811663R
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 75 KG