MAUDE Adverse Event Report: STRYKER SPINE-FRANCE LITE PLATE SYSTEM SOLID SCREWDRIVER; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	49177220
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/12/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a plate 23 length placed 4 22 l 5.0 screws tried to final seat with solid screwdriver.The tip broke in the screw head.The tip was left in screw head on lower sacral screws.
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment.The screwdriver was inspected and it was found that the tip was completely fractured off from the device.No relevant manufacturing issues were identified as all units met specifications.The possible root cause of the reported event is excessive force applied during screw tightening.
Event or Problem Description
It was reported that a plate 23 length placed 4 22 l 5.0 screws tried to final seat with solid screwdriver.The tip broke in the screw head.The tip was left in screw head on lower sacral screws.

• Brand Name: LITE PLATE SYSTEM SOLID SCREWDRIVER
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6307059
• Report Number: 0009617544-2017-00053
• Device Sequence Number: 19024822
• Product Code: LXH
• UDI-Device Identifier: 07613327275117
• UDI-Public: (01)07613327275117
• Combination Product (Y/N): N
• 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): 05/24/2017

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: 49177220
• Device Lot Number: 14J142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2017
• Supplement Report FDA Received Date: 05/24/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1