MAUDE Adverse Event Report: SYNTHES MONUMENT 10MM/130 DEG TI CANN TFNA 340MM/RIGHT ¿ STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.054S

Device Problem Break (1069)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Manufacturing location: (b)(4); manufacturing date: 23-oct-2015; expiration date: 30-sep-2025; part #: 04.037.054s, lot#: 9926305 (sterile), component parts reviewed: no ncrs 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.¿ the returned nail was received along with the concomitant helical blade (04.038.285) which was used during the initial procedure; since the blade was concomitant no investigation will be completed for it.The returned 10mm 130° ti trochanteric fixation nail advanced (tfna) nail (04.037.054s, 9926305) is part of tfna systems (dsus/trm/0815/0682, dsem/trm/0915/0523, dsem/trm/0514/0052) and is used for intramedullary fixation of proximal femoral fractures.The returned nail was received broken in the region where the helical blade was inserted; also both the returned nail and blade were received with superficial damage indicative of extraction.Replication of the complaint condition is inapplicable since the complaint condition was confirmed due to the returned nail being received broken.As part of this investigation a visual inspection, drawing review, root cause analysis, and risk management assessment were performed.The returned nail (04.037.054s, 9926305) was manufactured on 23oct15 and drawings were reviewed and determined to be suitable for the intended design, application, and dimensional conformity when used and handled as recommended.No mrrs, ncrs, or actions related to the complaint condition were generated during production of the returned part(s).Review of device history record(s) showed that there were no issues during the manufacture of the product(s) which would contribute to the complaint condition.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.Based on the available details it is not possible to determine a definitive root cause for the complaint condition; however it was noted that the patient had femur cancer and osteopenia, which could have contributed to inadequate healing and subsequently nail breakage.It was also stated that a bigger nail/helical blade was used during the revision surgery, so it is possible that the initial implants were undersized and contributed to the nail failure.During the investigation no unidentified product design issues or discrepancies were observed that may have contributed to the complaint condition.The associated dcrm adequately addresses the complaint condition and the calculated occurrence rate does not exceed established limits.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 the patient underwent revision surgery on (b)(6) 2017 due to a broken nail.The patient was originally implanted with a right trochanteric femoral nail-advanced (tfna) nail and helical blade on (b)(6) 2016.Original surgery was completed successfully without complications.The patient reported that she experienced pain for nine months and felt like she couldn¿t walk.Upon follow-up with her surgeon, it was determined by x-ray taken on (b)(6) 2017 that the nail was broken.Patient was returned to surgery on (b)(6) 2017 where the nail and helical blade were removed.Patient was revised to a larger nail and helical blade.Revision surgery was completed successfully without surgical delay.It is reported that, two (2) months post-operative, patient is able to walk.Concomitant medical products: helical blade (part 04.038.285, lot number unknown, quantity 1).This report is for one (1) tfna nail.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Additional patient identifier reported as (b)(6).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

Patient underwent a right femoral surgery on (b)(6) 2016.Patient experienced excruciating pain in the mid right thigh and she couldn't even stand up around (b)(6) 2017.Postoperative x-ray taken on (b)(6) 2017 revealed that the nail had completely broken in the region where the helical blade was inserted.On (b)(6) 2017, the patient was revised to a 340 mm synthes rod and 12 mm thickness, 85 mm triflange nail, 36 distal cortical screw.

• Brand Name: 10MM/130 DEG TI CANN TFNA 340MM/RIGHT ¿ STERILE
• Type of Device: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer (Section G): SYNTHES MONUMENT; 1051 synthes ave; monument CO 80132
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6513689
• MDR Text Key: 73449817
• Report Number: 1719045-2017-10335
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.037.054S
• Device Lot Number: 9926305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: HELICAL BLADE(04.038.285, LOT UNKNOWN, QTY 1)
• Patient Outcome(s): Required Intervention
• Patient Weight: 75