MAUDE Adverse Event Report: STRYKER SPINE-US ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802740
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the blades broke when inserting pedicle based retractor screw pin, during surgery.The short blade screw was replaced with a new one.There are no reports of adverse health consequences.
Additional Manufacturer Narrative
Method: device history review, complaint history review, risk assessment.Result: the customer reported event was confirmed via correspondence.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The product was not returned as it was discarded by the customer.Conclusion: since the product was not returned, root cause of the reported event could not be determined conclusively.Based on the risk file, potential root cause of the screw fracture may be application of too much torsional force while insertion of the screw pin.
Event or Problem Description
It was reported that one of the blades broke when inserting pedicle based retractor screw pin, during surgery.The short blade screw was replaced with a new one.There are no reports of adverse health consequences.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X40MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7298016
• Report Number: 0009617544-2018-00055
• Device Sequence Number: 16514911
• Product Code: NKB
• UDI-Device Identifier: 07613327002003
• UDI-Public: (01)07613327002003
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• 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): 06/21/2018

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: 482802740
• Device Catalogue Number: 482802740
• Device Lot Number: 169871
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR