MAUDE Adverse Event Report: SYNTHES USA PRODUCTS LLC TFNA HELICAL BLADE 100MM; ROD,FIXATION,INTRAMEDULLARY

Model Number 04.038.300

Device Problem Unintended Movement (3026)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Age or date of birth, gender, and weight not available for reporting.Date of device migration reported only as 2017.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 a patient underwent a second revision surgery on (b)(6) 2017 due to a trochanteric proximal femoral nail advanced (tfna) helical blade migrating into the femoral head for a second time.The initial surgery was conducted on an unknown date to implant one (1) tfna nail, one (1) helical blade and one (1) distal locking screw.On (b)(6) 2017, the helical blade was identified to have migrated into the femoral head and the surgeon conducted a revision surgery to engage the tfna locking mechanism which he believed to have forgotten to engage.This first revision surgery was successfully completed and is addressed in (b)(4).The patient reported back to the surgeon during a follow-up visit about feeling uncomfortable.X-rays taken on an unknown date since showed the helical blade had migrated into the femoral blade again into the same position.Based on this, the surgeon scheduled a second revision surgery for (b)(6) 2017.As planned, the surgeon removed the entire tfna construct and revised the patient to another tfna construct consisting of a nail with a larger diameter and a lag screw.The surgeon statically locked down the screw into the nail.This second revision surgery was successfully completed without any untoward incidents and the patient was reported to be stable on (b)(6) 2017.Concomitant devices reported: tfna nail (quantity 1), distal locking screw (quantity 1).This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis a device history record review was performed for the subject device lot number h343693.Manufacturing location: (b)(4).Date of manufacture: 24 may 2017 date of expiration: 30 april 2027.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformance's were generated during the production of the subject device.A visual inspection via the provided x-rays and pictures, drawing review, complaint history review, and risk assessment review were performed as part of this investigation.The complaint condition could not be confirmed.No new malfunctions were observed during the course of this investigation.The provide picture shows the proximal end of a tfna head element.Due to the resolution, minimal detail can be gathered, however, no product issues were observed in the image.The provided x-rays do not show the distal tip of the tfna helical blade which was reported to have cut out or the nail/blade junction.Thus, the complaint condition could not be confirmed.It was noted that the second x-ray is of a lag screw tfna head element and thus, is likely the result of the second revision of which there is no allegation.Based on the date of manufacture the following drawings, reflecting the current and manufactured revision, were reviewed.No product design issues were observed that may have contributed to the complaint condition.As the physical device was not received no further dimensional or material testing could be completed.No definitive root cause was able to be determined as circumstances surrounding the event are unknown and the device was not returned.It was reported that the user suspected they forgot to engage the locking mechanism during the initial surgery which would impact the compliant condition for the first migration.No design or manufacturing issue was identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Further it was reported that a patient underwent a series of surgeries following the movement of a trochanteric fixation nail (tfn) system's components caused due to failure of one (1) unknown locking bolt or screw, which led to an unknown component of this system to protrude excessively into patient's femur.There is also an allegation of an unknown vice or defect on the tfn system that cannot be seen by ordinary tests and that had occurred during manufacturing.This tfn system was initially implanted on (b)(6) 2017 into the patient's femur.Due to the protrusion of the device, the patient allegedly was unable to be fully functional for many months.The patient is reportedly partially disabled, i.E.They cannot engage in all of the activities of their work.Subsequent surgeries were unable to fully repair the damage to patient's body caused by the tfn system.There is a mention of several additional surgeries that the patient had to undergo subsequent to this tfn system¿s unknown device migration.The movement of tfn component leading to revision surgery has been captured under: (b)(4).

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.Additional narrative: patient identifier; event.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 HELICAL BLADE 100MM
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7052789
• MDR Text Key: 92768548
• Report Number: 2939274-2017-50024
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 10886982099020
• UDI-Public: (01)10886982099020(10)H343693
• Combination Product (y/n): N
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 04.038.300
• Device Catalogue Number: 04.038.300S
• Device Lot Number: H343693
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention