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

Model Number	48361235
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial handle broke during impaction.
Event or Problem Description
It was reported that the trial handle broke during impaction.

• Brand Name: SLIDE RASP 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: 7012202
• Report Number: 0009617544-2017-00403
• Device Sequence Number: 944765
• Product Code: LXH
• UDI-Device Identifier: 07613327269116
• UDI-Public: (01)07613327269116
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2018

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: 48361235
• Device Catalogue Number: 48361235
• Device Lot Number: 106245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/08/2017
• Supplement Report FDA Received Date: 01/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1