MAUDE Adverse Event Report: 3D SYSTEMS, INC. VSP SYSTEM; BONE CUTTING INSTRUMENT AND ACCESSORIES

Model Number VSPO

Device Problem Incorrect Device Or Component Shipped (2962)

Patient Problem Sedation (2368)

Event Date 06/16/2016

Event Type  Injury  

Manufacturer Narrative

Not returned.

Event Description

The patient specific intermediate surgical splints provided for a segmental lefort i, bsso, and genioplasty surgery were for the incorrect patient.The patient was under anesthesia prior to surgery when the error was recognized by the operating physician.Correct intermediate surgical splints were manufactured the same day and sent to the operating physician.The new intermediate splints were used in a successful follow-up surgery the following day ((b)(6) 2016) the sla 5000 arthroview build (3d printing) on (b)(6) 2016 failed entirely.The build contained vspo intermediate surgical splints, most of which were due to ship out on (b)(6) 2016.Due to this, three separate arthroview re-builds containing splints from the sla 5000 (b)(6) 2016 build were started on the morning of (b)(6) 2016.When the splints from the original ar5000 (b)(6) 2016 build platform were separated into three machines to be rebuilt, the intermediate surgical splints for wo#(b)(4) were mistakenly not loaded into any build.The device history records (travelers) on this day were paired with their corresponding accuview final surgical splints (that were built successfully on (b)(6) 2016), and those were inspected prior to the rebuilt arthroview splints from the three morning builds finishing production.When the rebuilt arthroview splints were ready for final inspection in the afternoon, they were paired with their associated case based off reading the work order # on the part itself and placing them into the bin containing the rest of the parts/documentation for that case.During the sorting process, intermediate surgical splints for (b)(4) were placed with the parts and documentation for work order # (b)(4) (likely because of the similarities in work order numbers).The operating physician provides digital stone models using the charlotte method on his cases, thus parts do not have associated physical stone models.This allows only a visual inspection and verifying the part's thickness during the final inspection process, and fit checks cannot be conducted.(b)(4) final inspection personnel did not verify the part's labeling during the inspection of the intermediate surgical splints (the rest of the case had already been checked).During final inspection by quality personnel, the intermediate surgical splints' part labels were also not verified.

• Brand Name: VSP SYSTEM
• Type of Device: BONE CUTTING INSTRUMENT AND ACCESSORIES
• Manufacturer (Section D): 3D SYSTEMS, INC.; 5381 south alkire circle; littleton CO 80127
• Manufacturer (Section G): HEALTHCARE; 5381 south alkire circle; littleton CO 80127
• Manufacturer Contact: scott brewer ; 5381 south alkire circle; littleton, CO 80127 ; 7206431001
• MDR Report Key: 5776957
• MDR Text Key: 49022327
• Report Number: 1724955-2016-00002
• Device Sequence Number: 1
• Product Code: DZJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120956
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VSPO
• Device Catalogue Number: N/A
• Device Lot Number: 71766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR