MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR C 7MM INSERTER; INSTRUMENT-INSERTER

Catalog Number 48328007

Device Problems Bent (1059); Material Deformation (2976)

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

Event Date 05/05/2014

Event Type  malfunction  

Event Description

It was reported that on inspection of loaner kit found that the 7mm was inserter bent & cross threaded.

Manufacturer Narrative

Method: functional device inspection; device history review; complaint history review; results: the probable cause is multifactorial in nature.Conclusion: the anchor c 7mm inserter was confirmed to have a bent shaft upon visual inspection.This issue was found during an inspection.There was not patient involvement or harm reported.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.

Event Description

It was reported that on inspection of loaner kit found that the 7mm was inserter bent & cross threaded.

• Brand Name: ANCHOR C 7MM INSERTER
• Type of Device: INSTRUMENT-INSERTER
• 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: 3841672
• MDR Text Key: 4662775
• Report Number: 0009617544-2014-00248
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102606
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48328007
• Device Lot Number: 111584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/23/2011
• 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