MAUDE Adverse Event Report: STRYKER SPINE-FRANCE UNKNOWN_SPINE_PRODUCT; PEDICLE SCREW SPINAL SYSTEM.

Catalog Number UNK_SPN

Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 01/05/2017

Event Type  malfunction  

Event Description

It was reported that a t1-t6 thoracic fracture fixation was being done and during final tightening one of the screws and both the blade and blocker snapped off within the final tightening tube.It was further reported that two blockers were placed down the final tightening tube causing excessive stress on the screw design.There was a surgical delay of 40 minutes.Case was finished without further issue and the fixation was completed as planned pre-op.Update: the blockers were tightened to a torque of 12nm - no more than the recommended amount.The blocker was not cross-threaded.No part/s of the blocker broke, the blades were broken and both they and the blocker/s were lodged within the final tightening tube.The screw blades, the screw tulip head remained intact.Two blockers were placed down the ft tube (surgeon was not aware of an existing blocker).All fragments remained within the final tightening tube.X-ray did not show any additional fragments the surgeon was concerned with.No other adverse consequences for the patient.Parts were disposed.

Manufacturer Narrative

Method: risk assessment; results: the devices were discarded therefore device evaluation, device history review and complaint history review could not be performed.Conclusion: the possible root cause of the reported event is user error.

Event Description

It was reported that a t1-t6 thoracic fracture fixation was being done and during final tightening, one of the screws and both the blade and blocker snapped off within the final tightening tube.It was further reported that two blockers were placed down the final tightening tube causing excessive stress on the screw design.There was a surgical delay of 40 minutes.Case was finished without further issue and the fixation was completed as planned pre-op.Update: the blockers were tightened to a torque of 12nm - no more than the recommended amount.The blocker was not cross-threaded.No part/s of the blocker broke, the blades were broken and both they and the blocker/s were lodged within the final tightening tube.The screw blades, the screw tulip head remained intact.Two blockers were placed down the ft tube (surgeon was not aware of an existing blocker).All fragments remained within the final tightening tube.X-ray did not show any additional fragments the surgeon was concerned with.No other adverse consequences for the patient.Parts were disposed.

• Brand Name: UNKNOWN_SPINE_PRODUCT
• Type of Device: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6282776
• MDR Text Key: 66224550
• Report Number: 0009617544-2017-00037
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNK_SPN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2017
• 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