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	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trial inserter broke inside the trial upon impaction.The tip of the inserter remained inside the trial.
Additional Manufacturer Narrative
Product information added to section.
Event or Problem Description
It was reported that the trial inserter broke inside the trial upon impaction.The tip of the inserter remained inside the trial.
Event or Problem Description
It was reported that the trial inserter broke inside the trial upon impaction.The tip of the inserter remained inside the trial.
Additional Manufacturer Narrative
Method: visual inspection, functional analysis, product history review, complaint history review, labelling review, risk assessment result: the tip of the inserter was found to be fractured off upon visual inspection.No relevant manufacturing issues were identified for the reported lot.It was reported that the during procedure impaction force was applied more than usual.The instrument ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.This device was more than 3 years old at the time of the reported event.Conclusion: the plausible root causes of the reported event are: extensive use of the instrument (normal wear and tear) and too much impaction force applied during insertion.

• 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: 7898539
• Report Number: 0009617544-2018-00230
• Device Sequence Number: 10805384
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: 07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 11/21/2018

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: 14H649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/08/2018; 10/27/2018
• Initial Report FDA Received Date: 09/21/2018
• Supplement Report FDA Received Date: 10/16/2018; 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1