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

Model Number	48759701
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon impacting the trial handle assembly, during an l2-l3 procedure, a piece of metal fell out of the connection point and the connection will no longer accept an instrument.The procedure was successfully completed and all fragments were retrieved.There were no adverse health consequences to the patient.
Additional Manufacturer Narrative
Lot #: 134822.The customer reported event was confirmed via visual inspection.The device was inspected and sign of usage and impaction on the handle end were observed.It's confirmed that one of the handle tulips fractured.The fragment was not returned.Manufacturing history was reviewed and no issues were identified.Age of the instrument was found to be approximately 4 years old.A most likely root cause of the event is normal wear and tear.The stryker instrument ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.The life of the instrument depends on the number of times they are used as well as the precautions taken in handling, cleaning and storage.Great care must be taken of the instruments to ensure that they remain in good working order.
Event or Problem Description
It was reported that upon impacting the trial handle assembly, during an l2-l3 procedure, a piece of metal fell out of the connection point and the connection will no longer accept an instrument.The procedure was successfully completed and all fragments were retrieved.There were no adverse health consequences to the patient.

• 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: 7294476
• Report Number: 0009617544-2018-00054
• Device Sequence Number: 894632
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/20/2018

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: Health Professional
• Device Model Number: 48759701
• Device Catalogue Number: 48759701
• Device Lot Number: 134822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Initial Date Received by Manufacturer: 01/29/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 02/24/2018
• Supplement Report FDA Received Date: 04/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1