MAUDE Adverse Event Report: STRYKER SPINE-FRANCE TRIO CONNECTOR ADAPTOR; INSTRUMENT-CONNECTOR ADAPTER

Catalog Number 47113055

Device Problem Difficult to Remove (1528)

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

Event Date 12/10/2013

Event Type  malfunction  

Event Description

It was reported, during surgery, it was found that the nut of connector adaptor could not be removed.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment.Results: the customer reported event of the trio connector adaptor locking nut was confirmed to be jammed via a functional evaluation of the returned device.The returned device was attempted to be disassembled but could not be because the locking nut was jammed.A material analysis was performed in a similar investigation and it was determined that galling was the cause of the seizure of the locking screw.Conclusion: the root cause of the reported event was determined to be galling between the locking nut and the connector head.

Event Description

It was reported, during surgery, it was found that the nut of connector adaptor could not be removed.

• Brand Name: TRIO CONNECTOR ADAPTOR
• Type of Device: INSTRUMENT-CONNECTOR ADAPTER
• 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: 3550171
• MDR Text Key: 4219021
• Report Number: 0009617544-2014-00003
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103292
• 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: 12/10/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 47113055
• Device Lot Number: 133834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2013
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 77 YR