MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM.3.5MM SELF DRILLING 10MM; IMPLANT-CERVICAL SCREW

Catalog Number 48335310

Device Problem Device Slipped (1584)

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

Event Date 01/09/2014

Event Type  malfunction  

Event Description

It was reported on the lateral x-ray, a screw appears to have backed out of the locking mechanism on caudle side or right side of patient.No replacement device or revision surgery has been planned at this time.

Manufacturer Narrative

Method: complaint history review; risk assessment.Results: the device was reported to be an anchor c diam.3.5mm self tapping 10mm bone screw was confirmed to be damaged as reported by the sales representative.The manufacturing records could not be checked for relevant anomalies because the lot # is unknown.The instructions for use detail warnings about post-operative care and pre-cautions.It is the responsibility of the surgeon to relay this information to the patient.The root cause of locking clip failures is being studied under a capa (pr #155364) which is currently still open.The following root causes were determined as a part of this capa: freehand use, inserter loosens during surgery, not fully threading inserter, unfamiliar with system, interaction between cage, screw and inserter, outer diameter of clip too large, general user error.Conclusion: findings indicate that locking clip deformation is generally a result of user error as well as screw design.

Manufacturer Narrative

Method: complaint history review; risk assessment; labeling review.Results: the customer reported event of the anchor c diam.3.5 mm self drilling 10 mm bone screw was confirmed to be backing out of the locking mechanism via sales rep.Anchor c surgical technique instructs the user not to excessively angle the screw driver while tightening the bone screw as it may lead to deformation of the bone screw or locking clip.A failure of the screw locking mechanism is the most likely cause of screws backing out.Also, the ifu for anchor c warns that delayed union can eventually lead to loosening, bending or fatigue fracture.An nc and capa were opened addressing locking clip failures.Conclusion: the root causes as part of the open capa determine the failure to be multifactorial.Most issues are result of user error.

Event Description

It was reported on the lateral x-ray, a screw appears to have backed out of the locking mechanism on caudel side or right side of patient.No replacement device or revision surgery has been planned at this time.

• Brand Name: ANCHOR C DIAM.3.5MM SELF DRILLING 10MM
• Type of Device: IMPLANT-CERVICAL SCREW
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer (Section G): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• Manufacturer Contact: daniel roberts ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 3603041
• MDR Text Key: 4089277
• Report Number: 3005525032-2014-00018
• Device Sequence Number: 1
• Product Code: OVE
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 48335310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 02/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR