MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED HELICAL BLADE 90MM - STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	04.038.390S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/03/2023
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 orif surgery for a femoral trochanteric fracture with end cap, tfna short nail and blade.Even though the blade was fully inserted, it was rotated 90 degrees from normal and the locking mechanism did not function.Therefore, the end cap could not be tightened.The surgery was completed successfully within 30 minutes delay.No further information is available.This report is for a tfna fenestrated helical blade 90mm ¿ sterile.This is report 3 of 3 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.H10 additional narrative: d2: additional procode: hsb.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10: date of concomitant therapy is 03-october-2023.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.

• Brand Name: TFNA FENESTRATED HELICAL BLADE 90MM - STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 17985683
• Report Number: 8030965-2023-13331
• Device Sequence Number: 18189060
• Product Code: KTT
• UDI-Device Identifier: 10886982099259
• UDI-Public: (01)10886982099259
• 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: 2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 04.038.390S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 10/23/2023
• 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 END CAP EXTENS. 0 TAN.; TFNA FEM NAIL Ø10 125° L170 TIMO15.
• Patient Sex: Unknown