MAUDE Adverse Event Report: SYNTHES BETTLACH 135 DEG TI LC-DHS® PLATE- STANDARD BARREL 8 HOLES/142MM; APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR

Catalog Number 481.180

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2015

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that the dhs plate broke postoperatively based on a bagatelle trauma on (b)(6) 2015.It was a device related explantation based on an implant fracture.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Implant and explant date unknown.The investigation could not be completed; no conclusion could be drawn, as no product was received.A review of the device history records has been requested.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: 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

Device was used for treatment, not diagnosis.The investigation could not be completed; no conclusion could be drawn, as no product was received.No ncrs 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.Reported on original medwatch as (b)(6) 2015.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A manufacturing investigation as well as a product evaluation was performed: 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 dhs plate.The implant could not resist the applied force which finally led to the material overload / fatigue failure.Postoperative activities of the patient may have played a certain role, too.We found no evidence of material or manufacturing defects.When examining the distal fracture surfaces (part a and b) of the dhs plate using the scanning electron microscope (sem), the areas of fracture initiation and the fracture behavior were identified.The crack started at the upper side of the plate and ran into the material.After breaking, the two plate fragments rubbed against each other, causing partly slight destruction of the fracture surfaces (abraded and shiny areas).At a higher magnification, fatigue striations were observed at the crack propagation zones.Each striation represents the successive position of an advancing crack front and they originate from cyclic loads (load and unload during walking).The presence of these striations is a clear indication of a fatigue process.The fracture surfaces showed mainly a transition zone with a mixed fracture of fatigue striations and dimples.The areas with dimples correspond with the residual forced fracture zone.The presence of the relatively great areas with mixed fracture and dimples (approx.60 %) indicates higher loads.Sem observations and findings showed that the plate failure was caused by fatigue and overload.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 was diagnosed with a subtrochanteric femoral fracture following dynamic hip system (dhs) removal fourteen days prior.The patient underwent an open reduction, re-implantation of dhs and a valgization corrective osteotomy.The initial femoral neck fracture occurred years ago.After having some of the devices removed, the patient had a fall resulting in a fracture at the level of the upper screw fixation of the dhs plate.

Manufacturer Narrative

Additional 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

The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 provided x-rays were reviewed by the manufacturer: the breakage of the plate could be confirmed.

• Brand Name: 135 DEG TI LC-DHS® PLATE- STANDARD BARREL 8 HOLES/142MM
• Type of Device: APPLIANCE,FIXATION DEVICE, PROXIMAL FEMUR
• Manufacturer (Section D): SYNTHES BETTLACH; muracherstrasse 3; bettlach PA 19380 CH2; SZ 19380 CH25
• Manufacturer (Section G): SYNTHES BETTLACH; muracherstrasse 3; bettlach CH25 44; SZ CH2544
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4559956
• MDR Text Key: 5457178
• Report Number: 2520274-2015-11371
• Device Sequence Number: 1
• Product Code: JDO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK953607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 481.180
• Device Lot Number: 2338086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2015
• Initial Date FDA Received: 03/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/09/2015; 03/10/2015; 03/13/2015; 04/01/2015; 08/04/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2008
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR