MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SINGLE SYRINGE SET; CEMENT / CEMENT ACCESSORY

Catalog Number 831215P

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 08/12/2014

Event Type  Injury  

Event Description

It was found the crack on the nozzle of the syringe during extruding cement for the treatment of the femoral neck fracture.Cement leaked from the damaged area.Another product was used to complete the case.There were no surgical delay and no adverse consequences to the patient.

Manufacturer Narrative

This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.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).

Manufacturer Narrative

The complaint stated that a crack arose in the cemvac nozzle and that cement leaked from it.The complaint sample was examined.The nozzle was cut to approximately 46 mm length.Presumably, the nozzle was cut because retrograde cement filling of the femur was completed and it was time to pressure the cement (using a pressurizer).There was a small crack / craze in the nozzle, around the interface of the bushing to the syringe barrel.The extent of the crack / craze could not be determined, as it was obscured by a small quantity of leaked cement.The piston was approximately 13mm from the end of its travel and some cement still remained within the system.The evidence suggests that the crack / craze occurred relatively late in the extrusion process, when the cement viscosity was high.However, the complaint does not indicate which bone cement was used in the procedure.The material for the nozzle tube is made from 95% fluorinated ethylene propylene (fep), with 5% polytetrafluoroethylene (ptfe).Fep resins are considered to be highly tough materials, that are not prone to fracture.Even after gamma sterilisation, the tube material remains tough.In a previous complaint (b)(4), nozzle bend tests were performed when bone cement (depuy cmw 1) was extruded late, with the cement almost hard and the cement exotherm had commenced.In those circumstances, when excessive force was applied, it was possible to produce a partially brittle fracture of the nozzle.However, even under those extreme (off-label) circumstances, the nozzle did not entirely break into two.Ductile yielding of the nozzle still occurred.A possible root cause of the current complaint (b)(4) is a fracture initiated in the nozzle when the bone cement was extruded late.In these conditions, the cement viscosity would have been extremely high.If the cement viscosity is extremely high, trigger of the cement delivery gun would exert extremely high hoop stresses in the syringe barrel and nozzle.These stresses could cause eventual fracture of the cemvac components.The most probable explanation for the complaint, is that the cement was extruded late, when the cement viscosity was excessively high.The cemvac single syringe kit is sold empty.The type of cement used was not specified in the complaint.The properties of bone cement can be affected by a number of external factors.For example: the type of bone cement used; the mixing time used for the cement; the extrusion time used for the cement; the quantity of bone cement used; the storage temperature of the cement; the temperature of the operating theatre; the use of vacuum mixing systems.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.

• Brand Name: SINGLE SYRINGE SET
• Type of Device: CEMENT / CEMENT ACCESSORY
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: steve dowell ; 700 orthopaedic drive; warsaw, IN 46581 ; 5743714918
• MDR Report Key: 4034141
• MDR Text Key: 18031953
• Report Number: 1818910-2014-26524
• Device Sequence Number: 1
• Product Code: LOD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 831215P
• Device Lot Number: 12110175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1