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

Model Number	GB70009S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
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 ; GM 12249
• MDR Report Key: 10682314
• Report Number: 3002949614-2020-00001
• Device Sequence Number: 19610878
• 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
• PMA/510(K) Number: K181026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• 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
• Operator of Device: No Information
• Device Expiration Date: 06/04/2025
• Device Model Number: GB70009S
• Device Catalogue Number: GB70009S
• Device Lot Number: MS1811663R
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2020
• Initial Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3002949614-09/3020-001-R
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75