MAUDE Adverse Event Report: SYNTHES MONUMENT 11MM/130 DEG TI CANN TFNA 170MM - STERILE; ROD,FIXATION,INTRAMEDULLARY

Catalog Number 04.037.142S

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Non-union Bone Fracture (2369); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient dob & weight not provided for reporting.Unknown when non-union started.(b)(4).Original surgery on (b)(6) 2016.Device is not expected to be returned for manufacturer review/investigation.(b)(4) used for: it was reported the locking mechanism in the nail broke and a fragment was left in the patient.The incision was left open with a wound vacuum for a future surgery to remove the embedded device.Device history records review was conducted.The report indicates that: manufacturing location: monument manufacturing date: 09-jan-2016.Expiration date: 30-nov-2025.Part #: 04.037.142s, lot#: 9976506 (sterile) - tfna-11mm/130 deg ti cann tfna 170mm - sterile.Qty.6.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.¿ 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 patient underwent original surgery on (b)(6) 2016 in hip to repair fracture of proximal femur and post operatively locking mechanism in trochanteric fixation nail advanced (tfna) nail broke.Revision surgery was performed on (b)(6) 2016 to remove hardware which includes a tfna nail, tfna helical blade 120 mm sterile and unknown locking screw.Surgeon did not attempted to retrieve the fragment of tfna nail from patient body and the fragment was left embedded in patient body.Surgeon was not able to close the incision and had to put on wound vacuum.There was no malfunction associated with helical blade and locking screw.Procedure was completed and there was no delay in surgery.Intra op x-ray was taken on (b)(6) 2016 and surgeon could not confirm the non union.Ct scan was performed post operatively and non union was confirmed.Surgeon is anticipating a revision surgery on (b)(6) 2016 for removal of fragment of tfna nail and irrigation and débridement of hip and biopsy of bone and also will close the incision.Surgeon is also anticipating a total hip surgery for patient with non synthes device in future.Surgeon decided not to perform revision surgery on (b)(6) 2016 and let patient heal on its own and the incision was closed.This complaint involves 3 devices.This report is 1 of 3 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: device available for evaluation?.(b)(4).A product development investigation was performed for the subject device (11mm/130 deg ti cann tfna 170mm - sterile, part number 04.037.142s, lot number 9976506).The subject device was returned with the complaint condition stating that post operatively the locking mechanism in trochanteric fixation nail advanced (tfna) nail broke.Revision surgery was performed to remove hardware which includes a tfna nail, tfna helical blade 120 mm sterile and unknown locking screw.Surgeon did not attempted to retrieve the fragment of tfna nail from patient body and the fragment was left embedded in patient body.Surgeon was not able to close the incision and had to put on wound vacuum.There was no malfunction alleged against the helical blade and locking screw.The returned implant is part of the depuy synthes tfn-advanced (tfna) proximal femoral nailing system.The helical blade/lag screw is used to prevent the nail from rotating once final position and locking has taken place per the associated technique guide.The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed.As previously reported, the review of the device history record revealed no complaint related anomalies.The device history record shows this lot of tfna ti helical blade 120mm 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 the locking mechanism on the tfna nail was confirmed to be broken at the prong.The nail also has surface scratches and wear consistent with implantation and removal.The complaint condition is confirmed.Although no definitive root cause was able to be determined the failure is potentially related to excessive forces on the device postoperatively or use error in tightening the locking mechanism during surgery.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The design history was not found to impact the complaint condition.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.The returned part was determined to be suitable for the intended use when employed.As previously reported, the review of the device history record revealed no complaint related anomalies.The device history record shows this lot of 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 11MM/130 DEG TI CANN TFNA 170MM - 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: mark vornheder ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6045289
• MDR Text Key: 58018673
• Report Number: 1719045-2016-10767
• 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
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• 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: 9976506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention