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

Model Number 48759701

Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Material Fragmentation (1261); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2017

Event Type  malfunction  

Event 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.

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 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
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer (Section G): STRYKER SPINE-FRANCE; zone industrielle de marticot; cestas 33610 ; FR 33610
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 6811843
• MDR Text Key: 83499374
• Report Number: 0009617544-2017-00328
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 07613327272772
• UDI-Public: (01)07613327272772(11)150506(10)AEJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 07/26/2017
• Supplement Dates FDA Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 72 YR