MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 80 - SILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	04.038.380S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent the orif surgery for femoral intertrochanteric fracture with tfna long.After the surgery on (b)(6) 2024, it was confirmed that the blade in question has reached the cut-through, and the second surgery was performed.The blade (80 mm) was removed and 75 mm blade was implanted.Cement augmentation was performed at the discretion of the surgeon after fully explaining and understanding that the use of cement is contraindicated in cases of perforated bone heads.The procedure was carefully performed to avoid cement leakage from the articular surface and from the fracture site, and 2 ml of cement was injected.Intraoperative imaging and postoperative x-rays confirmed the absence of cement leakage.The surgery was completed successfully with no surgical delay.No further information is available at this time.This report is for one (1) tfna fenestrated helical blade 80 - sile this is report 1 of 1 for complaint (b)(4).
Additional Manufacturer Narrative
Product complaint (b)(4) investigation summary product was not returned.Based on the information available, it has been determined that no corrective and 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.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: device history lot part# 04.038.380s lot # 7989p52 manufacturing site: depuy synthes products, inc supplier: (b)(4) release to warehouse date: 19 sep 2023 expiration date: 01 sep 2033 a manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified 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: TFNA FENESTRATED HELICAL BLADE 80 - SILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): WERK SELZACH LOGISTIK; bohackerweg 5; selzach CO 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 19715543
• Report Number: 8030965-2024-08495
• Device Sequence Number: 8609098
• Product Code: HSB
• UDI-Device Identifier: 10886982099211
• UDI-Public: (01)10886982099211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.038.380S
• Device Lot Number: 7989P52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female