MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 1.45 DIA GUIDEWIRE, BLU; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286705220
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
On (b)(6) 2014, the surgery for kyphoscoliosis was performed by using the viper system.In order to insert the sai screw, the guide wire was inserted from the sacrum to the iliac.When the tap was cut over the guide wire, the tip of the guide wire was broken.A broken piece was left in the patient.The broken piece was not removable.No further medical intervention is planned.The surgery was completed with a delay (less than 30 minutes).
Additional Manufacturer Narrative
Product complaint # (b)(4).One viper 1.37mm blunt guidewire was received by the customer quality unit for evaluation.Visual examination at the macroscopic level revealed that the fracture was located at the guidewire¿s distal tip.The second half of the guidewire¿s tip was not returned for analysis.The fracture analysis reveals torsional shear markings following a circular pattern.This suggests that the fractured tip underwent a quasi-static overload torsional shear failure starting at the outer surface and extending to the center of the shaft.The potential fracture termination site.No material defects or other abnormalities were observed in this analysis.A device history record review could not be conducted as a lot number is not available.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the guidewire fracturing could not be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure.No material defects or other abnormalities have been identified in the fracture analysis report.Therefore, this complaint file will be closed with no further action required.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER2 1.45 DIA GUIDEWIRE, BLU
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7390273
• Report Number: 1526439-2018-50289
• Device Sequence Number: 709425
• Product Code: LXH
• UDI-Device Identifier: 10705034213682
• UDI-Public: (01)10705034213682
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: Health Professional
• Device Model Number: 286705220
• Device Catalogue Number: 286705220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 03/16/2018
• Initial Report FDA Received Date: 04/02/2018
• Supplement Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR