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 Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the threaded portion of the shaft broke off while in patient.Trial was removed using a kocher.A surgical delay of approximately 1 minute was reported.Surgery was completed successfully.No adverse consequences reported.
Additional Manufacturer Narrative
Method: visual inspection, product history review, complaint history review, nc/capa history review, labelling review, risk assessment result: upon visual inspection, the tip of the inserter was found to be fractured off.No relevant manufacturing issues were identified for the reported lot.The instrument ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.This device was almost 9 years old at the time of the reported event.Conclusion: the plausible root cause of the event determined to be the age of the device- "normal wear based on age and extensive use of the device".
Event or Problem Description
It was reported that the threaded portion of the shaft broke off while in patient.Trial was removed using a kocher.A surgical delay of approximately 1 minute was reported.Surgery was completed successfully.No adverse consequences 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: 7831422
• Report Number: 0009617544-2018-00211
• Device Sequence Number: 13832322
• Product Code: LXH
• UDI-Device Identifier: 07613327269147
• UDI-Public: 07613327269147
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 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: 093085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 08/29/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1