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

Model Number	48759701
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; during insertion of the trial with the handle, a piece of metal break off of it.Issue occured while malleting the handle into the disc space.The disc space had been cleaned out and the disc had already been removed.The patient had average disc space nothing out of the ordinary.Issue occured at l3 l4.All broken fragments were retrieved.No adverse consequences to the patient nor surgical delay.Back up handle was used to successfully complete procedure.
Additional Manufacturer Narrative
The device was inspected and sign of usage and impaction on the handle end were observed.It's confirmed that the handle tulips fractured.The device has been manufactured for around 1.5 years and has sign of wear after long-term usage.No relevant manufacturing issues were identified as all units met specifications conclusion: the most likely cause of the reported event was determined to be the overload during long-term usage.
Event or Problem Description
It was reported that; during insertion of the trial with the handle, a piece of metal break off of it.Issue occured while malleting the handle into the disc space.The disc space had been cleaned out and the disc had already been removed.The patient had average disc space nothing out of the ordinary.Issue occured at l3 l4.All broken fragments were retrieved.No adverse consequences to the patient nor surgical delay.Back up handle was used to successfully complete procedure.

• 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: 6893407
• Report Number: 0009617544-2017-00367
• Device Sequence Number: 898766
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/28/2017

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 Model Number: 48759701
• Device Catalogue Number: 48759701
• Device Lot Number: 14E588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Initial Date Received by Manufacturer: 08/30/2017
• Supplement Date Received by Manufacturer: 08/30/2017
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 12/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 82