MAUDE Adverse Event Report: STRYKER SPINE-FRANCE SLIDE TRIAL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	48361234
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	05/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; in surgical procedure scheduled for monday (b)(6), the breakdown of the end part of occurred, the threaded end part remained inside the trial metal cage , the metal cage remained inside the intersomal space in the patient, a mechanical gripper was used for its removal, a time of 15 minutes of delay with difficult removal.Without using the trial, the physician had to use the "cage " metal trial cages present in the hospital.Disk space has been emptied and worked with tools dedicated to preparation of the disk.The trial cage is placed on the insert.The insertion was beaten with a hammer to place the cage inside the space.The insertion broke.The trial cage was removed with mechanical clamp.There were no consequences for the patient, but they lost 15 minutes for removal with a tool not dedicated to the front surgery near vases in a complex anatomy.
Event or Problem Description
It was reported that; in surgical procedure scheduled for monday 29 may the breakdown of the end part of occurred, the threaded end part remained inside the trial metal cage , the metal cage remained inside the intersomal space in the patient, a mechanical gripper was used for its removal, a time of 15 minutes of delay with difficult removal.Without using the trial, the physician had to use the "cage " metal trial cages present in the hospital.Disk space has been emptied and worked with tools dedicated to preparation of the disk the trial cage is placed on the insert.The insertion was beaten with a hammer to place the cage inside the space.The insertion broke.The trial cage was removed with mechanical clamp.There were no consequences for the patient, but they lost 15 minutes for removal with a tool not dedicated to the front surgery near vases in a complex anatomy.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 6668007
• Report Number: 0009617544-2017-00260
• Device Sequence Number: 16389970
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• 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): 09/21/2017

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: 48361234
• Device Catalogue Number: 48361234
• Device Lot Number: 14H647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 05/31/2017
• Initial Report FDA Received Date: 06/26/2017
• Supplement Report FDA Received Date: 09/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1