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

Model Number	48361235
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	05/01/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the trial distal tip broke.The surgery was successfully completed and there was no adverse health consequences to the patient.
Event or Problem Description
It was reported the trial distal tip broke.The surgery was successfully completed and there was no adverse health consequences to the patient.
Additional Manufacturer Narrative
The reported event was confirmed via email correspondence with the sales rep and visual inspection of the returned product.No relevant manufacturing issues were found.The instrument's ifu states: "while rare, intraoperative fracture or breakage of instruments can occur.Instruments which have experienced extensive use or extensive force are more susceptible to fracture depending on the operative precaution, number of procedures, and disposal attention.Instruments must be examined for wear or damage prior to surgery." based on the age of the device it is likely that the device fractured due to normal wear and tear.

• Brand Name: SLIDE RASP HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7557627
• Report Number: 0009617544-2018-00114
• Device Sequence Number: 1556123
• Product Code: LXH
• UDI-Device Identifier: 07613327269116
• UDI-Public: (01)07613327269116
• 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): 09/25/2018

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: 08C841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 05/01/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1