MAUDE Adverse Event Report: STRYKER SPINE-FRANCE REFLEX-HYBRID SCREW EXTRACTOR INNER SHAFT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48511905R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the draw rod of the screw extractor tip broke off and screw during extraction.Update additional information from rep confirmed that the revision surgery was performed for extension."this was a revision surgery, acdf was being extended.Patient needed to fuse in an additional level.The screw was not broken, it was intact.".
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: the reported event was confirmed via visual inspection of the returned product.The tip of the extractor was found to be fractured off.The fractured piece was not returned.No relevant manufacturing issues were found upon device history review.The probable root cause of this reported event is normal wear of instruments.
Event or Problem Description
It was reported that the draw rod of the screw extractor tip broke off and screw during extraction update: additional information from rep confirmed that the revision surgery was performed for extension."this was a revision surgery, acdf was being extended.Patient needed to fuse in an additional level.The screw was not broken, it was intact.".

• Brand Name: REFLEX-HYBRID SCREW EXTRACTOR INNER SHAFT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 7200075
• Report Number: 0009617544-2018-00015
• Device Sequence Number: 1028562
• Product Code: LXH
• UDI-Device Identifier: 07613327276831
• UDI-Public: (01)07613327276831
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 03/29/2018

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: 48511905R
• Device Catalogue Number: 48511905B
• Device Lot Number: 08D745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 01/17/2018
• Supplement Report FDA Received Date: 03/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1