MAUDE Adverse Event Report: SYNTHES GMBH DRIVE SHAFT FOR RIA 2 520MM; REAMER

Model Number 03.404.035

Device Problems Break (1069); Off-Label Use (1494)

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

Event Date 03/16/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023 for a revision surgery of a supracondyler femur fracture, a zimmer ncb plate was removed for a non union.The ria was used off label at the discretion of the surgeon by inserting the device through the non union site on the distal lateral side of the femur.While using the ria to collect graft, the at the end of the drive shaft that connects to the the reamer head, the prongs broke in the intramedullary canal.The reamer head was intact and removed by removing the ball tip guide wire.The 3 broken prongs for the drive shaft were removed with a pituitary ronguer.Added 5 minutes to case.No other issues.A replacement drive shaft is needed.Concomitant device reported: unk - reamers: reamer head (part# unknown; lot# unknown; quantity: 1).Unk - guide/compression/k-wires (part# unknown; lot# unknown; quantity: 1).This report is for one (1) drive shaft for ria 2 520mm this is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d2b: additional product code: hrx.D9: complainant part is not expected to be returned for manufacturer review/investigation.G4 510k: premarket submission number not available/not released h3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DRIVE SHAFT FOR RIA 2 520MM
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16761572
• MDR Text Key: 313522218
• Report Number: 8030965-2023-04796
• Device Sequence Number: 1
• Product Code: HTO
• UDI-Device Identifier: 10886982274243
• UDI-Public: (01)10886982274243
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.404.035
• Device Catalogue Number: 03.404.035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - GUIDE/COMPRESSION/K-WIRES; UNK - REAMERS: REAMER HEAD