MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA SCREW 80MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.038.080S

Device Problem Unintended Movement (3026)

Patient Problems Hearing Impairment (1881); Failure of Implant (1924); Impaired Healing (2378); No Code Available (3191)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Patient¿s weight is unknown.Udi: (b)(4) expiration date unknown lot number unknown.(therapy date): unknown.It is unknown if the scheduled hardware removal and revision surgery took place on (b)(6) 2017.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 with a trochanteric fixation nail advanced (tfna) experienced a severe cut out of the lag screw on (b)(6) 2017 and was confirmed by x-rays on (b)(6) 2017.Revision surgery is scheduled for (b)(6) 2017 to remove the nail and perform either a bi-polar or a total hip replacement.Concomitant devices reported: nail (04.037.042s, lot # unknown, quantity: 1), distal locking screw (04.005.524, lot # unknown, quantity: 1).This report is for one (1) tfna screw 80mm - sterile.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Device remained implanted.Device is not expected to be returned for manufacturer review/investigation.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 further reported that the revision is postponed indefinitely.Patient was not cleared for surgery.Reason is unknown but, unrelated to device.Parts remained implanted in patient and will not be returned.

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

It was further reported that the trochanteric fixation nail advanced (tfna) implant occurred on (b)(6) 2017.The surgeon reported that this event was a nonunion and that there was some healing at the greater trochanter, but very little healing anywhere else.

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

(b)(4).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 further reported that initially the patient¿s revision surgery had been postponed indefinitely due to pneumonia.The patient had only achieved partial healing and underwent hardware removal and revision surgery on (b)(6) 2017.The nail, lag screw and distal locking screw were removed easily.Patient was revised to a bipolar hip with depuy synthes reclaim stem.The surgery was completed successfully without any surgical delay and the patient was reported as stable.

• Brand Name: TFNA SCREW 80MM - STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6787891
• MDR Text Key: 82474753
• Report Number: 3003506883-2017-10157
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.080S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: LOCKING SCREW (PART 04.005.524, LOT UNK, QTY 1); NAIL (PART 04.037.042S, LOT UNKNOWN, QUANTITY 1)
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR