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

Model Number	48759701
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; trial handle tip of knob or trial handle broke off during surgery.2 tabs, one may have already been missing, other may have off.During surgery while inserting the trial, the surgeon softly impacted the handle and the tip of the knob, where the handle connects to the trial, broke off.One tab of the instrument may have already been missing.The other tab fell off during this surgery and was successfully retrieved.While using the second back up handle, when the handle was taken off to take an x-ray, metal fragments came off.There were no adverse consequences to the patient.Surgery was successfully completed with the second trial handle.Both instruments were previously used successfully.Rep had the set for 2 weeks and it was used 3x successfully.
Additional Manufacturer Narrative
The returned trial handle was inspected visually.Sign of wear after long-term usage was observed and no fracture can be found.No failure was detected on the returned product.
Event or Problem Description
It was reported that; trial handle tip of knob or trial handle broke off during surgery.2 tabs, one may have already been missing, other may have off.During surgery while inserting the trial, the surgeon softly impacted the handle and the tip of the knob, where the handle connects to the trial, broke off.One tab of the instrument may have already been missing.The other tab fell off during this surgery and was successfully retrieved.While using the second back up handle, when the handle was taken off to take an x-ray, metal fragments came off.There were no adverse consequences to the patient.Surgery was successfully completed with the second trial handle.Both instruments were previously used successfully.Rep had the set for 2 weeks and it was used 3x successfully.

• 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: 6811843
• Report Number: 0009617544-2017-00328
• Device Sequence Number: 13478027
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772(11)150506(10)AEJE
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 10/27/2017

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: 14C904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 07/26/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR