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	01/02/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the quick release handles broke during surgery.All the broken fragments were retrieved.No adverse health consequences were reported.
Event or Problem Description
It was reported that the quick release handles broke during surgery.All the broken fragments were retrieved.No adverse health consequences were reported.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: 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 almost 3 years old.It was reported that the instrument has been used hundreds times.Conclusion: a most likely cause of the reported event was determined to be the overload and normal wear and tear.The stryker instrument ifu indicates that instruments that have experienced extensive use or extensive force are more susceptible to fracture.

• 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: 7222729
• Report Number: 0009617544-2018-00022
• Device Sequence Number: 764168
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772
• Combination Product (Y/N): N
• 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
• 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: No Information
• Device Model Number: 48759701
• Device Catalogue Number: 48759701
• Device Lot Number: 14C157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2018
• Initial Date Received by Manufacturer: 01/02/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 01/26/2018
• 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