MAUDE Adverse Event Report: SYNTHES ELMIRA TFNA HELICAL BLADE 105MM STERILE; ROD, FIXATION, INTRAMEDULLARY

Catalog Number 04.038.305S

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Failure of Implant (1924); Perforation (2001); Loss of Range of Motion (2032); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4).The subject device is not expected to be returned to the synthes manufacturer for evaluation.(b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: sep 8, 2015.Expiration date: aug 1, 2025.The device history record shows this lot of tfna helical blade 105mm sterile product was processed through the normal manufacturing and inspection operations with no rework or non-conformities noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications with no non-conformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Synthes europe reported an event in (b)(6) as follows: it was reported that on (b)(6) 2017 the surgeon found that the trochanteric fixation nail ¿ advanced (tfna) helical blade had penetrated the acetabular roof.The patient is having difficulty walking.The patient was initially implanted on (b)(6) 2016 to treat a trochanteric fracture.Due to the reported event, revision surgery including a total hip arthroplasty is planned.It is not known on what date the revision surgery is scheduled for.Concomitant medical products: 1x 04.005.530s / 9882724 (lockscr ø5 l40 f/nails tan light green); 1x 04.037.912s / 9962895 (tfna fem nail ø9 125° l170 timo15); 1x 04.038.000s / 9347629 (tfna end cap extens.0 tan).This report is 1 of 1 for (b)(4).

Manufacturer Narrative

A product investigation was completed: product 04.038.305s with lot 9870334 was not returned.Complained issue (the blade penetrated acetabular roof) could be confirmed based on the provided x-rays.Root cause could not be defined due the device not being returned.No indication for product related issue was found.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 105MM 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: 6341558
• MDR Text Key: 67801381
• Report Number: 3003506883-2017-10021
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.038.305S
• Device Lot Number: 9870334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 04.005.530S, 5.0MM TI LOCKING SCREW 40MM, QTY 1; 04.037.912S, 9MM/125 DEG TI CANN TFNA 170MM, QTY 1; 04.038.000S, TI END CAP FOR TFNA 0MM EXTN, QTY 1
• Patient Outcome(s): Required Intervention