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

Model Number GB70009S

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2020

Event Type  malfunction  

Event 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
• Type of Device: INTRAMEDULLARY FIXATION SYSTEM
• Manufacturer (Section D): MERETE GMBH; alt-lankwitz 102; berlin, berlin 12249 ; GM 12249
• Manufacturer (Section G): ARISTOTECH INDUSTRIES GMBH; im biotechnologiepark; luckenwalde, brandenburg 14943 ; GM 14943
• Manufacturer Contact: paul münch ; alt-lankwitz 102; berlin, berlin 12249 ; GM 12249
• MDR Report Key: 10682314
• MDR Text Key: 213920617
• Report Number: 3002949614-2020-00001
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 04048266179623
• UDI-Public: (01)04048266179623(17)250604(10)MS1811663R
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: GB70009S
• Device Catalogue Number: GB70009S
• Device Lot Number: MS1811663R
• Date Manufacturer Received: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3002949614-09/3020-001-R
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75