MAUDE Adverse Event Report: SYNTHES GMBH TFNA HELICAL BLADE PERF L85 TAN; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number 04.038.385S

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Additional product code: ktt, appliance, fixation, nail/blade/plate combination, multiple component complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.

Event Description

It was reported that on (b)(6) 2021, the patient underwent surgery for trochanteric fracture of femur with the tfna implants in question.The surgery was completed successfully with no surgical delay.Over-sliding occurred a few weeks after the surgery, so the fixation was maintained thereafter.But approximately 3 weeks ago, the patient started to complain pain.It was confirmed by x-ray that the position of the blade in the bone head moved to the proximal side of the bone head.The head was probably inverted or rotated.The patient underwent careful rehabilitation and was followed up, but the change in the position of the blade did not stop, so it was decided that the revision surgery via bha would be performed before cut-out occurred.The surgeon attributed the cause of the event to lack of fixation ability due to improper reduction at the initial surgery.The surgeon does not consider the event to be causally related to the products.No further information is available.This complaint involves one (1) device tfna helical blade perf l85 tan.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA HELICAL BLADE PERF L85 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 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13652970
• MDR Text Key: 286453069
• Report Number: 8030965-2022-01282
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 07611819652569
• UDI-Public: (01)07611819652569
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• 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
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.385S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/02/2022
• Initial Date FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKSCR Ø5 L38 F/NAILS TAN LIGHT GREEN; TROCHANT FEM NAIL 10 125 L20
• Patient Outcome(s): Required Intervention