MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ES2 INTEGRATED BLADE SCREW SIZE S 7.5X55MM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	482802755
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient underwent an l5-s1 tlif procedure on (b)(6) 2018.On (b)(6) 2018, the doctor found that the blade was not cut as expected, and a part of the blade remained on the screw, on the right of l5, in the patient's cavity.The doctor thought this occurred because the blade remover was not completely inserted in the blade when cutting.At this time, additional treatment is not planned.
Additional Manufacturer Narrative
Method: product history review, complaint history review, labelling review, risk assessment result: the reported event was confirmed via communication with sales representative.The device was disposed of in the hospital, thus unavailable for evaluation.Two possible lot numbers were provided for the device.Manufacturing records were reviewed for both lot numbers provided and no relevant issues were identified.The surgical technique defines a step by step process for removing blade using blade remover.Per communication with sales representative, the user did not fully seat the instrument on the blade which might have led to breakage of blade on application of force.The most probable root cause of the reported event was determined to be user error.
Event or Problem Description
It was reported that the patient underwent an l5-s1 tlif procedure on (b)(6) 2018.On (b)(6) 2018, the doctor found that the blade was not cut as expected, and a part of the blade remained on the screw, on the right of l5, in the patient's cavity.The doctor thought this occurred because the blade remover was not completely inserted in the blade when cutting.At this time additional treatment is not planned.

• Brand Name: ES2 INTEGRATED BLADE SCREW SIZE S 7.5X55MM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7309109
• Report Number: 0009617544-2018-00057
• Device Sequence Number: 1605334
• Product Code: NKB
• UDI-Device Identifier: 07613327002034
• UDI-Public: (01)07613327002034
• Combination Product (Y/N): N
• PMA/510(K) Number: K122845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2018

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: Health Professional
• Device Model Number: 482802755
• Device Catalogue Number: 482802755
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR