MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L90 TAN; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number 04.038.390S

Device Problems Device Slipped (1584); Material Protrusion/Extrusion (2979); Positioning Problem (3009)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: hsb.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.(b)(4).A review of the device history record has conducted.No non-conformances have been identified.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 (b)(6) as follows: it was reported that on (b)(6) 2022, the patient underwent the open reduction internal fixation surgery for trochanter of femur fracture with the blade in question.This was a surgery with extra short nail and blade and no agmt cement.The surgery was completed successfully without any surgical delay.After the surgery, the patient started ambulatory rehabilitation early.One week after the surgery, the bone head had slid to the edge of blade, and the blade penetrated the bone head in the second week.At present, the patient does not complain of pain, but in consideration of the above situation as seen on an x-ray, the surgeon has instructed to the rehabilitation department to handle it carefully.The surgeon commented as follows.More compression was applied to the bone fracture part than capacity of the sliding distance of the blade.The reduction position was not good.Intraoperative compression should have been applied.Initial blade length selection was too long.Based on these possible factors, reoperation is planned on (b)(6) 2022.No further information is available.This complaint involves one (1) device tfna helical blade perf l90 tan.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA HELICAL BLADE PERF L90 TAN
• Type of Device: 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: 14024747
• MDR Text Key: 288786763
• Report Number: 8030965-2022-02215
• Device Sequence Number: 1
• Product Code: KTT
• Combination Product (y/n): N
• PMA/PMN Number: K160167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.390S
• Device Lot Number: 342P011
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - END CAPS: TFNA; UNK - NAILS: TFNA; UNK - SCREWS: NAIL DISTAL LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female