MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ANCHOR L SCREWDRIVER MODULAR RIGID; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	48999000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; our sales rep reported: "during the step of putting the screw on the cage implanted, the terminal part of the screwdriver broke.The tip of it was stuck in the screw.The doctor removed it by unscrewing the screw implanted with a forceps.The tip is still stuck inside the screw, but the screw has been removed and it will be returned.The doctor has implanted a new screw with a screwdriver replacement.The implant is correctly positioned and locked.There were no consequences for the patient.Time used for removal 45 minutes, the removal was not easy".
Additional Manufacturer Narrative
Visual inspection, device history review, complaint history review, risk assessment.It was confirmed that the tip had fractured off of the driver.No relevant issues were found in the manufacturing records of the device lot that may have contributed to the reported event.Based on the information provided, the root cause of the reported event is multifactorial.
Event or Problem Description
It was reported that; our sales rep reported: "during the step of putting the screw on the cage implanted, the terminal part of the screwdriver broke.The tip of it was stuck in the screw.The doctor removed it by unscrewing the screw implanted with a forceps.The tip is still stuck inside the screw, but the screw has been removed and it will be returned.The doctor has implanted a new screw with a screwdriver replacement.The implant is correctly positioned and locked.There were no consequences for the patient.Time used for removal 45 minutes, the removal was not easy".

• Brand Name: ANCHOR L SCREWDRIVER MODULAR RIGID
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6387855
• Report Number: 0009617544-2017-00080
• Device Sequence Number: 16281205
• Product Code: LXH
• UDI-Device Identifier: 07613327274905
• UDI-Public: (01)07613327274905
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2017

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 Catalogue Number: 48999000
• Device Lot Number: 142599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR