MAUDE Adverse Event Report: STRYKER SPINE-SWITZERLAND XIA PRECISION SCREW 7.5 X 55MM; PEDICLE SCREW SPINAL SYSTEM.

Model Number	48231755
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the rod was cut.While bending the vitallium rod with the french bender the product broke in half on the back table about 2 inches in.During surgery while putting the rod in the screw the head fell off of the screw.The screw was already in the patient.All broken fragments retrieved.
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment; the customer reported event was confirmed via visual inspection.The screw was returned in 2 pieces.The tulip head was disengaged from the main thread body.No relevant manufacturing issues were identified as all units met specifications.The plausible root cause of the event was determined to be excessive insertion force applied during insertion leading to disengagement.
Event or Problem Description
It was reported that; the rod was cut.While bending the vitallium rod with the french bender the product broke in half on the back table about 2 inches in.During surgery while putting the rod in the screw the head fell off of the screw.The screw was already in the patient.All broken fragments retrieved.

• Brand Name: XIA PRECISION SCREW 7.5 X 55MM
• Common Device Name: PEDICLE SCREW SPINAL SYSTEM.
• Manufacturer (Section D): STRYKER SPINE-SWITZERLAND; le crêt-du-locle 10 a; -; la chaux-de-fonds 2300 ; CH 2300
• MDR Report Key: 6498772
• Report Number: 3005525032-2017-00050
• Device Sequence Number: 248595
• Product Code: NKB
• UDI-Device Identifier: 07613154088942
• UDI-Public: (01)07613154088942
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2017

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: 48231755
• Device Catalogue Number: 48231755
• Device Lot Number: A81887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/17/2017
• Supplement Report FDA Received Date: 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 159