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

Model Number	04.038.380S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from japan reports an event as follows: it was reported that on (b)(6) 2023, the patient underwent the open reduction internal fixation with the tfna nail and the blade for the femoral trochanteric fracture.After insertion of the nail, the blade, the augmentation, and the locking screws, the image showed that medial cortex of femoral diaphysis and the nail covered.It was confirmed that the nail was not inserted into the medullary cavity and was loosened backward.The surgeon removed the blade and the nail once, the nail was re-inserted.However, the hollow part was stuck with cement and the guide pin could not be inserted.The surgeon inserted a new 85 mm blade.At first, the surgeon selected the 80 mm blade for cement injection when the measurement was 85 mm.There was still space for the femoral head, and a longer blade was selected.If all 85 mm blade was inserted, the distance between the blade tip and the femoral head would become too short.Therefore, the blade was adjusted about 3 mm before all 85 mm blade was inserted.Then, the locking mechanism was tightened.The surgery was completed successfully within 10 minutes delay.The surgeon commented that the greater trochanter and lesser trochanter minor had been severely cracked and crushed, so that the nail got loosened.Although the surgeon checked the lateral side by the image, it looked as if it had been inserted into the medullary cavity.The surgeon did not suspect anything.In addition, the patient had a poor bone quality, so that the surgeon could not feel the nail in the medullary cavity compared to when it was inserted incorrectly or when it was inserted successfully.No further information is available.This report is for a tfna fenestrated helical blade 80mm ¿ sterile.This is report 1 of 1 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Additional narrative: additional procode: ktt.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.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: TFNA FENESTRATED HELICAL BLADE 80MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES SELZACH; bohackerweg 5; selzach 2545 ; SZ 2545
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA ; 3035526892
• MDR Report Key: 16444284
• Report Number: 8030965-2023-02369
• Device Sequence Number: 5872575
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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 Model Number: 04.038.380S
• Device Catalogue Number: 04.038.380S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 02/27/2023
• 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: TFNA FEM NAIL Ø10 R 125° L235 TIMO15; UNK - BIOMATERIAL - CEMENT; UNK - SCREWS: LOCKING; UNK GUIDE PIN
• Patient Age: 86 YR
• Patient Sex: Female