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

Catalog Number	48759701
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/03/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; the collar of the trial handle broke off.
Additional Manufacturer Narrative
Lot# 14e857; visual inspection; device history review; complaint history review; risk assessment.Manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The most likely cause of the reported event was determined to be the overload during usage.
Event or Problem Description
It was reported that; the collar of the trial handle broke off.

• 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: 6067911
• Report Number: 0009617544-2016-00433
• Device Sequence Number: 18985389
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772
• 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: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2017

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: 14E857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2016
• Supplement Report FDA Received Date: 01/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1