MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 5.5 X 35MM; IMPLANT-LUMBAR SCREW

Catalog Number 03829535

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2014

Event Type  malfunction  

Event Description

It was reported that during routine scoliosis surgery, due to misplacing the screwdriver on the screw by the nurse, surgeon tried to implant and forced the screw in that condition without knowing that it is misplaced which resulted in deformation and partial breakage on the screwdriver and deformation of the screw.However the surgery is completed with other screw and screwdriver which is in the kit.No adverse event has happened and no delay occurred in the surgery.

Manufacturer Narrative

Correction: the device did not contribute to the customer reported event and is a concomitant product.Xia screw did not malfunction, xia screw driver did: mdr mfg reference #0009617544-2014-00106.

Event Description

It was reported that during routine scollosis surgery, due to misplacing the screwdriver on the screw by the nurse, surgeon tried to implant and forced the screw in that condition without knowing that it is misplaced which resulted in deformation and partial breakage on the screwdriver and deformation of the screw.However the surgery is completed with other screw and screwdriver which is in the kit.No adverse event has happened and no delay occurred in the surgery.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 5.5 X 35MM
• Type of Device: IMPLANT-LUMBAR SCREW
• 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: 3673296
• MDR Text Key: 21496692
• Report Number: 0009617544-2014-00105
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K061854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03829535
• Device Lot Number: 126579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/18/2014
• 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