MAUDE Adverse Event Report: SYNTHES GMBH HIP SCR FOR IM NL 6.5/L=85/XL40/SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.046.685S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 reported that on feb 27, 2024, the surgeon was treated this patient with frna gt nail.While implanting the femoral nail a 3.2x400 wire missed the hole through the nail.The wire was hitting the nail at an incorrect angle and under xray imaging see the trajectory wasn¿t the same as the tracer trajectory.This step in the surgical technique was repeated several times to see why this step wasn¿t working.This created an issue because the second recon screw wasn't able to be implanted as it wouldn¿t fit through the nail.There wasn¿t a delay in surgery cause 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.No adverse consequences that affected the patient.This report is for one (1) hip scr for im nl 6.5/l=85/xl40/sile.This is report 1 of 3 for complaint: (b)(4).

• Brand Name: HIP SCR FOR IM NL 6.5/L=85/XL40/SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK GRENCHEN (CH); solothurnstrasse 186; grenchen 2540 ; SZ 2540
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 18921829
• Report Number: 8030965-2024-03758
• Device Sequence Number: 7515035
• Product Code: HSB
• UDI-Device Identifier: 10886982301994
• UDI-Public: (01)10886982301994
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• 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

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: 04.046.685S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 10 / TI CANN FRN / GT 400 / RIGHT - SILE; LCKNG SCR FOR IM NL 5/ 36/ XL25/ SILE
• Patient Age: 18 YR
• Patient Sex: Male
• Patient Weight: 82 KG