MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 6MM SELF DRILLING TAP,; TAP, BONE

Model Number	286715600
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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) 2018, the mis-plif surgery for lumbar spinal canal stenosis was performed by using the viper 2 system.The fixed site was l5-s.The following event occurred during the surgery.The surgeon created 2.6 mm of prepared hole using the power tool, and then applied tapping by 6mm using a guide wire.At the time of perforating with a ratchet handle, a large noise of ¿click¿ was heard throughout the operating room.It was found that the large noise had occurred because the tip of the drilling tap (supposed to be part#: 286715600) go broken, and the broken tip was also found left between the patient¿s pedicle and vertebral body.Considering the patient on dialysis, the surgeon applied the following procedures.The broken tip of the drilling tap was not extracted from the patient¿s body, because the removal of the broken tip would likely cause bleeding.The fixed site was extended to an upper vertebral body to enhance the fixation.The surgery was completed with a 180-minute delay.
Additional Manufacturer Narrative
Product complaint # (b)(4).Visual examination at the macroscopic level revealed that the fractured occurred at the tap¿s distal tip.The second half of the distal tip was not provided for analysis.The fracture analysis report reveals plastic deformation and torsional shear markings following a circular pattern around the cannulation.This suggests that the tap¿s distal tip underwent a quasi-static torsional shear failure.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.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the tap¿s distal tip fracturing cannot be positively determined.However, the fracture analysis report suggests that the tap¿s distal tip underwent a quasi-static torsional shear failure.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, 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 6MM SELF DRILLING TAP,
• Common Device Name: TAP, BONE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7782297
• Report Number: 1526439-2018-50785
• Device Sequence Number: 16451199
• Product Code: HWX
• UDI-Device Identifier: 10705034214092
• UDI-Public: (01)10705034214092
• 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: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 286715600
• Device Catalogue Number: 286715600
• Device Lot Number: NG58647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/27/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR