MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA II UNIVERSAL TIGHTENER 5MM; INSTRUMENT-TIGHTENER

Catalog Number 03807008

Device Problem Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2014

Event Type  malfunction  

Event Description

It was reported that the blocker fell off the t-handle.

Manufacturer Narrative

Method: device history review; complaint history review; results: the device in question was not returned, so inspections could not be performed that could aid in root cause determination.As a result, the root cause of the issue cannot be determined conclusively.Conclusion: the customer reported event of the xia ii universal tightener not holding a xia blocker was confirmed via the correspondence with the sales rep.However, no device was returned for further evaluation.The event resulted in no delay or adverse consequences, which is in line with the referenced risk table.No manufacturing issues were identified during lot history review.

Event Description

It was reported that the blocker fell off the t-handle.

• Brand Name: XIA II UNIVERSAL TIGHTENER 5MM
• Type of Device: INSTRUMENT-TIGHTENER
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 3361 0; FR 33610
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3671395
• MDR Text Key: 4347166
• Report Number: 0009617544-2014-00102
• Device Sequence Number: 1
• Product Code: KWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03807008
• Device Lot Number: 066250
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2007
• 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