MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND ANCHOR C DIAM 3.5MM SELF DRILLING 10MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 6741610

Device Problems Break (1069); Flaked (1246); Fracture (1260); Use of Device Problem (1670); Malposition of Device (2616); Material Integrity Problem (2978)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2016

Event Type  malfunction  

Event Description

It was reported that; during an c case, doctor attempted to put the self-drilling screws into the cage without pre-drilling/tapping.He did not lock the screws into the cage.An x-ray was taken confirming that neither screw was in the vertebral body and had skived off the endplates.The screws were removed from the cage while the inserter was still attached (meaning he couldn't see the screws to engage the screwdriver), the dr.Then pre-drilled holes and put the same screws back into the cage as they had not been locked in initially.Just before closing the wound, dr.Noticed dark specs of metal within the soft tissues surround the cage which he believes is metal from the c kit.The screw driver, inserter, and hand drill were all checked for damage and all were in good condition.I did take a photo, which does show that the anterior square of the screw, where the screwdriver engages, is damaged and rounded off.This is presumed to have occurred when removing the screws from the cage.Update: 13-sep-2016.Surgeon believes he removed all the pieces, however he wasn't 100%.

Manufacturer Narrative

Method: risk assessment; results: device history review, visual inspection and complaint history review was not performed as the lot # is unknown.Conclusion: the possible root cause of this event is not determined as the product was not returned for evaluation.

Event Description

It was reported that; during an c case, doctor attempted to put the self-drilling screws into the cage without pre-drilling/tapping.He did not lock the screws into the cage.An x-ray was taken confirming that neither screw was in the vertebral body and had skived off the endplates.The screws were removed from the cage while the inserter was still attached (meaning he couldn't see the screws to engage the screwdriver), the dr.Then pre-drilled holes and put the same screws back into the cage as they had not been locked in initially.Just before closing the wound, dr.Noticed dark specs of metal within the soft tissues surround the cage which he believes is metal from the c kit.The screw driver, inserter, and hand drill were all checked for damage and all were in good condition.I did take a photo, which does show that the anterior square of the screw, where the screwdriver engages, is damaged and rounded off.This is presumed to have occurred when removing the screws from the cage.Update: 13-sep-2016 - surgeon believes he removed all the pieces, however he wasn¿t 100%.

• Brand Name: ANCHOR C DIAM 3.5MM SELF DRILLING 10MM
• Type of Device: PEDICLE SCREW SPINAL SYSTEM
• 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: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5993124
• MDR Text Key: 56824598
• Report Number: 3005525032-2016-00120
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 09/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 6741610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2016
• 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