MAUDE Adverse Event Report: DEPUY SYNTHES SPINE EXPEDIUM SI INTERMEDIATE TIGHTENER; SCREWDRIVER

Catalog Number 279712550

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

It had been reported that revision surgery was performed due to a broken expedium rod and possible infection.During the procedure, the surgeon had difficulty removing expedium single inner set screws due to stripping of the inner hex features and decided not to remove them.The tips of two moss miami si final tighteners were stripped during the procedure.Medwatch reports were filed for the implant devices due to the possible infection (including the broken rod and six expedium single inner set screws), and two moss miami si final tighteners that were stripped.In addition, external damage to the expedium si intermediate tightener, (b)(4), wasn¿t apparent when the complaint was reported or upon receipt of the instrument for evaluation.Further investigation of the returned intermediate tightener determined that the hex lobes on the distal end of the instrument were torn.As a result, this mfg.Medwatch report 1526439-2014-11913 is being submitted for the expedium si intermediate tightener.

Manufacturer Narrative

Device manufacture date: jan-30-2012; feb-02-2012.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 expedium si intermediate tightener was returned for evaluation.Visual inspection found some of the lobes partially torn off.This damage is sufficient enough to interfere with the functionality of the instrument.A review of the device history record (dhr) identified no issues during the manufacturing and release of this product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis for this device code found no related complaints.The root cause cannot be positively determined based on the samples and information provided.However a potential root cause may be wear and tear after repeated use as the driver are greater than 2 years old.No corrective or preventative action (capa) is necessary at this time as there has been no observed systemic trend.Therefore, the complaint 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: EXPEDIUM SI INTERMEDIATE TIGHTENER
• 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: 4105713
• MDR Text Key: 16779042
• Report Number: 1526439-2014-11913
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 279712550
• Device Lot Number: GM3423302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/01/2014
• 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