MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.033.002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on an unknown date in 2024, the patient was treated with an frna gt nail.While implanting the nail, a 3.2 x 400 wire missed the hole through the nail.The wire was hitting the nail at an incorrect angle.Under x-ray imaging it was observed that the trajectory was the same as the tracer trajectory.This step of the surgical technique was repeated several times, creating an issue because the second recon screw wouldn¿t fit through the nail.This screw could not be implanted.No further information is available.This report is for a radiolucent aiming arm/frn piriformis fossa.This is report 6 of 7 for (b)(4).
Additional 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.H10 additional narrative: b3: event occurred on an unknown date in 2024.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.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.
Event or Problem Description
It was further reported that there wasn¿t a delay in surgery caused by this event.The frna implant has two different proximal locking options."recon locking¿ and the other ¿standard locking¿.Since recon locking wasn¿t working the surgeon was able to preform ¿standard locking¿.The surgery was completed successfully.There was no adverse patient consequence.
Additional 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.D10: therapy date is (b)(6) 2024.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: RADIOLUCENT AIMING ARM/FRN PIRIFORMIS FOSSA
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 18921906
• Report Number: 8030965-2024-03750
• Device Sequence Number: 7589262
• Product Code: HSB
• UDI-Device Identifier: 10886982271068
• UDI-Public: (01)10886982271068
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K172157
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.033.002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 3.2MM TROCAR FOR RECON LOCKING; AIM-ARM RADIOLUC F/GREATER TROCHANTER FE; CANNULATED CONNECTING SCREW; DRILLSL 8.5/3.2 F/03.010.075; DRIVING CAP/THREADED; INSERT-HANDLE RADIOLUC FEM RECON NAIL; PROTECT SLEEVE 11.5/8.5 F/LFN RECOLOCK
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 82 KG