MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA LP POLYAXIAL SCREW 5.5 X 40MM; PEDICLE SCREW SPINAL SYSTEM

Catalog Number 03821540

Device Problems Break (1069); Detachment Of Device Component (1104); Mechanical Problem (1384); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2015

Event Type  malfunction  

Event Description

It was reported that; surgeon was performing a scoliosis surgery.Surgeon was derotating with tubes and screws and the screw head broke and separated from the body.Surgeon proceeded to remove that screw and changed by another one.Again, during derotation, the screw was broken.He removed the screw, placed a new one and again, during the rotation, the screw broke.At a total, 3 screws were broken on the attempts.No impact to the patient was caused.Surgery was delayed in 20 minutes, due to the replacement of screws.

Manufacturer Narrative

Method: visual inspection; functional inspection; device history review; complaint history review; risk assessment; results: protrusion of the bone screw through the base of the tulip was observed and suggests that excess torque was applied during the derotation maneuver.Review of the correspondence confirms that the event occurred during a derotation maneuver involving multiple suk tubes attached to the screws, clamped together.Conclusion: various surgical factors may have contributed to the event, involving the positioning of the tubes and the surgeon's technique.However, these factors could not be replicated during device evaluation, and as a result the root cause of the reported event could not be determined conclusively.

Event Description

It was reported that; surgeon was performing a scoliosis surgery.Surgeon was derotating with tubes and screws and the screw head broke and separated from the body.Surgeon proceeded to remove that screw and changed by another one.Again, during derotation, the screw was broken.He removed the screw, placed a new one and again, during the rotation, the screw broke.At a total, 3 screws were broken on the attempts.No impact to the patient was caused.Surgery was delayed in 20 minutes, due to the replacement of screws.

• Brand Name: XIA LP POLYAXIAL SCREW 5.5 X 40MM
• 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: 5009071
• MDR Text Key: 24435108
• Report Number: 3005525032-2015-00097
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K060361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/22/2015

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: No Information
• Device Catalogue Number: 03821540
• Device Lot Number: B47271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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