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

Catalog Number	48361234
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that a trial inserter tip broke upon impaction.No delay and no adverse consequences to the patient is reported.
Additional Manufacturer Narrative
Method: visual inspection, functional inspection, product history review, complaint history review, labelling review, risk assessment.Result: the reported event was confirmed via correspondence with the sales representative, as well as visual inspection of the returned device.Per correspondence with the representative, the disc space was not too tight with the trial size used (12x28x33x12 deg).The surgery was performed at the l4-5 level.The surgeon did not apply any cantilever force when the tip broke off.No distraction was applied during trial insertion.There were no broken fragments.The instrument has been used several hundreds of times.The representative has had the instrument for 5 years.The ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.This device was almost 10 years old at the time of the reported event.Conclusion: plausible root cause is concluded to be "normal wear based on age and extensive use of the device.".
Event or Problem Description
It is reported that a trial inserter tip broke upon impaction.No delay and no adverse consequences to the patient is reported.

• 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: 7598024
• Report Number: 0009617544-2018-00140
• Device Sequence Number: 2221750
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: 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): 08/26/2018

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 Catalogue Number: 48361234
• Device Lot Number: 088296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/21/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1