MAUDE Adverse Event Report: DEPUY SYNTHES SPINE 5.5 VIPER UNIV POLY DRIVER; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 279734000N

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Not Applicable (3189)

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Device is available for evaluation.Investigation will be conducted.Follow up with be filed with investigation results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Tip of navigated expedium screwdriver broke off in screw due to schlerotic bone.Screw removed using 35mm rod and lock screw and helicoptered the implant out.Patient consequence? :no.Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.

Manufacturer Narrative

Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip, the second half of the tip was not provided for evaluation.Device was then sent for fracture analysis.The fracture analysis report reveals plastic deformation at the hexlobes and torsional shear markings following a circular pattern.The plastic deformation at the hexlobes indicates a torsional overload.This suggests that the driver underwent a quasi-static overload torsional shear failure.No material defects or other abnormalities have been identified in the fracture analysis report.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause for the driver¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report suggests that the driver underwent a quasi-static overload torsional shear failure.No corrective action/preventive action (capa) is necessary at this time as no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Additionally, 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: 5.5 VIPER UNIV POLY DRIVER
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle ; CH
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808100
• MDR Report Key: 7048138
• MDR Text Key: 93088487
• Report Number: 1526439-2017-50011
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 10705034388410
• UDI-Public: 10705034388410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 279734000N
• Device Lot Number: GM4338401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1