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

Model Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a piece at the tip of the trial inserter broke off inside the trial, while testing for size in the patient.A backup instrumentt was used to remove the trial.The procedure was successfully completed.There are no reports of adverse health consequences to the patient.
Additional Manufacturer Narrative
Visual, dimensional and functional analysis could not be performed as the device was not returned.No lot # was provided, so a manufacturing record review could not be performed.The definitive root cause of the event cannot be determined from the given information.Potential root causes according to the risk table include previously deformed/damaged trial/handle, excessive rotational/torsional force applied, incorrect alignment, insufficient heat treatment, incorrect design and cross threading.
Event or Problem Description
It was reported that a piece at the tip of the trial inserter broke off inside the trial, while testing for size in the patient.A backup instrument was used to remove the trial.The procedure was successfully completed.There are no reports of adverse health consequences to the patient.

• Brand Name: SLIDE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-US; 2 pearl court; allendale NJ 07401
• MDR Report Key: 7356727
• Report Number: 0009617544-2018-00071
• Device Sequence Number: 13734218
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: (01)07613327269147
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/22/2018

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: Health Professional
• Device Model Number: 48361234
• Device Catalogue Number: 48361234
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/23/2018
• Supplement Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 06/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1