MAUDE Adverse Event Report: DEPUY SYNTHES SPINE ISOLA ILIAC SCREW PROBE STARTER

Catalog Number 205047

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2014

Event Type  malfunction  

Event Description

International affiliate reports that during posterior fusion for correction of idiopathic scoliosis with expedium 5, the tip of the probe snapped off in the pedicle of the patient.The broken tip was removed from the pedicle with a resulting delay of twenty minutes to the procedure.The patient was not adversely affected.The broken tip was lost at the hospital and will not be returned.

Manufacturer Narrative

A follow up report will be filed upon completion of the investigation.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

The isola iliac probe was returned for evaluation.Visual inspection revealed that the probe had fractured at its distal tip, the second half of the tip was not provided with the device.Scanning electron microscopy (sem) found evidence of plastic deformation and a rough/grainy fracture texture, indicating a static bending fracture.Additionally, this analysis found no material defects or other abnormalities.Based on the age of the device and the sem analysis, the fracture is not related to a material defect nor manufacturing issue and as such a review of the device history record (dhr) is deemed not necessary.A 12 month review of the complaint trend analysis for the isola probe was conducted on the specific code from the complaint as there is no device family for this instrument.This analysis found no emerging trends.The root cause of the isola iliac probe¿s distal tip becoming fractured cannot positively be determined.However, the sem fracture analysis results show evidence of plastic deformation and a rough/grainy texture, indicating a static bending fracture at the distal tip of the probe.No corrective action/preventive action (capa) is necessary at this time as there have been no material defects or other abnormalities observed in the fracture analysis report.Additionally, no observed systemic trends were identified.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: ISOLA ILIAC SCREW PROBE STARTER
• Type of Device: PROBE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: anita barnick ; 325 paramount drive; raynham, MA 02767 ; 5088283583
• MDR Report Key: 3803151
• MDR Text Key: 4366120
• Report Number: 1526439-2014-11499
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 205047
• Device Lot Number: H0701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1