MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM DRIVER SHAFT FOR SI SCREWS; SCREWDRIVER

Catalog Number 279712150

Device Problems Material Deformation (2976); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2014

Event Type  malfunction  

Event Description

International affiliate had reported ¿old instrument has failed¿.Clarification was requested and it was reported that there was no breakage or adverse patient impact reported.There was no further information for the complaint.Based upon the information provided, it appeared that the two expedium driver shafts for si screws were worn from use.However, evaluation of returned complaint samples on (b)(6) 2014 found the threads on the driver shafts were torn.The following mfg.Medwatch reports are being filed for the two expedium driver shafts for si screws: 1526439-2014-12036; 1526439-2014-12037.

Manufacturer Narrative

Visual examination of the returned expedium driver shaft for si screws noted that the distal tip was worn.In addition, it was indicated that the shaft¿s threads have become torn/peeled off.No other anomalies were observed during evaluation.Review of the device history record found no discrepancies.A 12-month review of the complaint trend analysis on the product code found no emerging trends.The root cause of the distal tip of the screwdriver becoming worn and the shaft¿s threads becoming torn cannot positively be determined.However, on assessment of the condition and age of the instruments, one possible root cause for this fault may most likely be attributed to wear and tear.Additionally, the noted torn threads on the shaft, most likely has been attributed to the driver not being fully seated in a screw head during insertion.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends have been observed, 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.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EXPEDIUM DRIVER SHAFT FOR SI SCREWS
• Type of Device: SCREWDRIVER
• 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: 4205984
• MDR Text Key: 4981175
• Report Number: 1526439-2014-12037
• Device Sequence Number: 1
• Product Code: HXX
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 279712150
• Device Lot Number: 0605NT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2014
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1