MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L80 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.380S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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 product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.Postal code (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.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 Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2022, the patient underwent an orif surgery for the basicervical neck fracture of the right femur with the tfna implants.The surgery was completed successfully without any surgical delay.After the surgery, the patient was brought to the hospital by ambulance with complaint of pain in the proximal femur on (b)(6) 2022.It was confirmed by x-ray that the tfna blade in question cut out forward.The tfna will be removed and replaced with bha on (b)(6) 2022.The surgeon commented that the defect was due to the poor bone quality of the patient and not the product itself.The patient's poor bone quality was due to a past medical history, but it will not be disclosed because of personal information.No further information is available.This report is for one (1) tfna helical blade perf l80 tan.This is report 2 of 4 for complaint (b)(4).6.Tests/lab data including dates.

• Brand Name: TFNA HELICAL BLADE PERF L80 TAN
• Type of Device: 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
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf ; SZ ; 6103142063
• MDR Report Key: 15192285
• MDR Text Key: 297527244
• Report Number: 8030965-2022-05668
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652552
• UDI-Public: (01)07611819652552
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.380S
• Device Lot Number: 94P6620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 92 YR
• Patient Sex: Female