MAUDE Adverse Event Report: SYNTHES SALZBURG 4.9MM TI LOCKING BOLT 42MM; PIN, FIXATION, SMOOTH

Catalog Number 459.420

Device Problem Component or Accessory Incompatibility (2897)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  malfunction  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the proximal femoral nail antirotation (pfna) broke postoperatively 8-10 weeks after implantation.This report is 3 of 3 for complaint (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Initial reporter: telephone number: (b)(6).The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records was performed and no complaint related issues were found.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Additional narrative: the device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.No non-conformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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

Additional narrative: an investigation summary was performed.The investigation of the complaint articles has shown that: the investigations included to inspect the manufacturer documents, technical drawing and the raw-material inspection sheet of the supplier.The proximal fracture surfaces (part a and b) of the implant were investigated by scanning electron microscopy (sem).Based on the topography of the fracture surface, we can conclude that the implant* was subjected to high dynamic bending loads (one sided).Constantly alternating load cycles (during walking) led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the pfna*.The nail* could not resist the applied force which finally led to the material overload / fatigue failure.Postoperative activities of the patient and a possible instability of the fracture situation (multifragmentary bone fracture) may have played a certain role, too.We found no evidence of material or manufacturing defects.A manufacturing investigation action was conducted/performed.The report indicates that: the bolt have no effect on the pfna-nail fracture.The nail broke through the distal blade bore in the area of the primary bone fracture.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)(6).Implant date: unknown; reported as 8-10 week prior to explant on (b)(6) 2014.Device was reported as received on previous follow up reports; adding date device was received by the manufacturer.Device is not distributed in the united states, but is similar to device marketed in the usa.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

The patient was diagnosed with a fracture of the proximal femoral nail anti-rotation (pfna) following an internal fixation of a pertrochanteric comminuted fracture of the left femur with pfna.The patient had been managed with a pfna for a pertrochanteric comminuted femoral fracture a good 8-10 weeks previously.The patient had recently experienced pain in the hip while weight bearing.An x-ray showed a suspected fracture of the nail in the area of the femoral neck blade, which was confirmed on a ct scan.The patient underwent a revision procedure where the pfna was removed and the patient was re-fixed with a pfna 130deg, diameter 12mm, length 240mm.

• Brand Name: 4.9MM TI LOCKING BOLT 42MM
• Type of Device: PIN, FIXATION, SMOOTH
• Manufacturer (Section D): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer (Section G): SYNTHES SALZBURG; karolingerstrasse; salzburg 5020 ; AU 5020
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4350832
• MDR Text Key: 5173682
• Report Number: 3000270450-2014-10178
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK970733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 459.420
• Device Lot Number: 5927188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 12/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/12/2015; 04/15/2015; 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1