MAUDE Adverse Event Report: STRYKER SPINE-FRANCE RADIUS M A ADJUSTMENT TOOL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	486619100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; upon removing a previously implanted screw from a patient's spine due to adjacent level disease, a piece of the multi-angle adjustment tool tip broke off.The instrument was removed, and the broken piece was found immediately and removed from the wound.The surgeon used the multi angle screwdriver to remove the rest of the remaining screws.
Additional Manufacturer Narrative
Lot #: 140989.The customer reported event was confirmed via visual inspection.The tip of the device was found to be fractured.Manufacturing history was reviewed and no issues were identified.A root cause of the event is overloading of the device and deviation from surgical technique, specifically not using a recommended tool during the procedure.
Event or Problem Description
It was reported that; upon removing a previously implanted screw from a patient's spine due to adjacent level disease, a piece of the multi-angle adjustment tool tip broke off.The instrument was removed, and the broken piece was found immediately and removed from the wound.The surgeon used the multi angle screwdriver to remove the rest of the remaining screws.

• Brand Name: RADIUS M A ADJUSTMENT TOOL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6846172
• Report Number: 0009617544-2017-00351
• Device Sequence Number: 518780
• Product Code: LXH
• UDI-Device Identifier: 07613327276053
• UDI-Public: (01)07613327276053
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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: 486619100
• Device Catalogue Number: 486619100
• Device Lot Number: 140989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/10/2017
• Supplement Date Received by Manufacturer: 08/10/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR