MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.037.142S

Device Problem Unintended Movement (3026)

Patient Problem Failure of Implant (1924)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Date of device migration is unknown date in 2017.This report is for an unknown tfna nail/unknown lot.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 was involved in a surgery to correct the locking on the trochanteric fixation nail - advanced (tfna) since the helical blade had penetrated through the femoral head and about one to two (1-2) millimeters into the joint space.The tfna construct was initially implanted about four to five months prior to this event.It was noted the device may not have been locked during the initial procedure which may have led to the helical blade migrating into the joint space.The migration was discovered on an x-ray on (b)(6) 2017.During the revision surgery (b)(6) 2017, the surgeon put an extractor on the helical blade to back it up, and then he locked the helical blade on the tfna nail.The surgery was reported to be completed uneventfully and successfully.The patient was reportedly stable post-operatively.A few days later the patient reported feeling uncomfortable.An x-ray showed that the helical blade locking mechanism was not engaged and had migrated into the femoral head again.The devices were removed in another procedure on (b)(6) 2017.This event is captured in related complaint (b)(4).This report is for an unknown tfna nail.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

Sterile part 04.037.142s, lot h401074: manufacturing location: (b)(4).Manufacturing date: july 11, 2017.Expiration date: may 31, 2027.Inspection sheet met inspection acceptance criteria.Component parts were reviewed and met specification.Raw material was reviewed and met specification.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Sterility documentation was reviewed and determined to be conforming.A product investigation was completed: the reported device was not received for investigation.The investigation is based on the reported information and provided x-rays and picture.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 locking mechanism or any evidence of locking mechanism malfunction.It was reported that the user suspected they forgot to engage the locking mechanism during the initial surgery.However, with the given information, the complaint condition could not be confirmed.The relevant drawings were reviewed.During the investigation 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.It was reported that the user suspected they forgot to engage the locking mechanism during the initial surgery which would impact the complaint condition of migration.However, as the device was not retuned a root cause could not be determined.No design of manufacturing issue was identified.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.

Manufacturer Narrative

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

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).

• Brand Name: 11MM/130 DEG TI CANN TFNA 170MM - STERILE
• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195120
• MDR Report Key: 7045841
• MDR Text Key: 92529262
• Report Number: 2939274-2017-50013
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131548
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.142S
• Device Lot Number: H401074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2018
• Date Device Manufactured: 07/11/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention