MAUDE Adverse Event Report: STRYKER SPINE-FRANCE ARIA ENCORE TRIAL HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.

Catalog Number	48759701
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Visual inspection; device history review; complaint history review; risk assessment the reported event of device fracture was confirmed by visual inspection.No relevant manufacturing issues were identified as all released units met stryker specifications.The plausible root cause for the reported event is likely due to the overload during usage.
Event or Problem Description
It was reported that while pulling the trial handle out the during procedure, the inner locking sleeve broke from the trial handle.

• Brand Name: ARIA ENCORE TRIAL HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT.
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• MDR Report Key: 5552282
• Report Number: 0009617544-2016-00143
• Device Sequence Number: 13574647
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772(11)150424(10)153904
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 03/10/2016

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: 48759701
• Device Lot Number: 153904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2016
• Initial Report FDA Received Date: 04/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1