MAUDE Adverse Event Report: STRYKER SPINE-FRANCE XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 35MM; PEDICLE SCREW SPINAL SYSTEM

Model Number	03829630
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during the operation, the universal screw was implanted and the nail head was unable to operate and the screws were not implanted properly.Additional information noted the following; it would have been necessary to implant 6 screws.But in the end, only 5 screws were fixed to perform the operation.
Additional Manufacturer Narrative
Visual analysis; device history review; complaint history review; risk assessment; the tulip head was found to have partially disengaged from the screw.Manufacturing records were reviewed for the corresponding lot, and no relevant issues were identified.The plausible root causes include the application of excessive force, the application of off-axis loading, and the screw not securely engaged with the screwdriver.
Event or Problem Description
It was reported that; during the operation, the universal screw was implanted and the nail head was unable to operate and the screws were not implanted properly.Additional information noted the following; it would have been necessary to implant 6 screws.But in the end, only 5 screws were fixed to perform the operation.

• Brand Name: XIA DEFORMITY REDUCTION LONG ARM POLYAXIAL SCREW 6.5 X 35MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6655094
• Report Number: 0009617544-2017-00253
• Device Sequence Number: 13857036
• Product Code: MNH
• UDI-Device Identifier: 07613154407866
• UDI-Public: (01)07613154407866
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K061854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2017

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
• Operator of Device: No Information
• Device Model Number: 03829630
• Device Catalogue Number: 03829635
• Device Lot Number: 157351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/25/2017
• Supplement Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 08/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 52