MAUDE Adverse Event Report: SYNTHES ELMIRA LOCKING CALCANEAL PLATE SHORT-LEFT; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM

Catalog Number 241.623

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the locking calcaneal plate broke postoperatively.A reoperation for removal was necessary.No additional information was reported.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Date of birth reported only as 1941.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

A review of the device history record revealed no complaint related anomalies.The device history record shows lot 6916797 of locking calcaneal plate, short ¿ left was processed through the normal manufacturing and inspection operations with no rework or nonconformances 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.

Manufacturer Narrative

(b)(4): subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn.A review of the device history records has been requested.Common device name: does not entirely fit into its respective field: appliance, fixation, nail/blade/plate combination, multiple component, metal composite.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 evaluation was completed: the calcaneal locking plate broke approximated 17 mm from its distal end.The investigations included to inspect the manufacturer documents, technical drawing and the raw-material inspection sheet of the supplier.The anterior fracture surface of the implant was investigated by scanning electron microscopy (sem).The plate is made of stainless steel.The examination of the manufacturing documents of the producer and the raw-material inspection sheet of the supplier showed no deviation in relation to the chemical composition, microstructure and mechanical properties.The material of the plate is in compliance with the international standards.The dimensions of the investigated plate (as far as measurable) were checked using a digital sliding caliper and found to be in compliance with the technical drawing of the producer and ao/asif specifications.The plate showed some scratches and mechanical damages which are caused during explantation.No abnormalities were found.When examining the distal fracture surface of the plate using sem, the initial fracture area and the fracture behavior were identified.The crack started at the plantar side of the plate and ran into the material.After breaking, the two plate fragments rubbed against each other causing partly strong destruction of the fracture surfaces (abraded and shiny areas).At a higher magnification, fatigue striations were observed at the crack propagation zones and over the entire fracture surface.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 the striations is a clear indication of a fatigue process.Sem observations and findings show that the plate failure was caused by fatigue and overload.Based on the topography of the fracture surface, we can conclude that the implant was subjected to low dynamic bending loads (one sided).Constantly alternating load cycles (during walking) over a long period of time led to the fatigue of the material, then to a first crack and finally to the overload respectively to the fatigue fracture of the plate.The plate 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.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: LOCKING CALCANEAL PLATE SHORT-LEFT
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM
• Manufacturer (Section D): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer (Section G): SYNTHES ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 3831643
• MDR Text Key: 4401489
• Report Number: 2520274-2014-11602
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK991407
• 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: 05/05/2014

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: 241.623
• Device Lot Number: 6916797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2015
• Initial Date FDA Received: 05/26/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/02/2015; 01/16/2015; 04/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR