MAUDE Adverse Event Report: DEPUY SPINE INC VIPER2 5MM SELF DRILLING TAP,; TAP, BONE

Model Number	286715500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the 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
It was reported the surgeon was tapping over a wire into very sclerotic bone on the concave side of a scoliotic curve.The tap began "squeak" and became hard to turn.Suddenly it began to spin freely as we noticed that it had broken in the bone.The surgeon then "retrieve" the wire from the bone and determined that it would be more detrimental to retrieve the broken component than it would be to simply leave it in.Was surgery delayed due to the reported event? yes.Action taken when event occurred? none - determined to be more invasive to retrieve piece.Was procedure successfully completed? yes.Were fragments generated? yes.If yes, were they removed easily without additional intervention? unknown.Patient status/ outcome / consequences? unknown.Was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required? unknown.Is the patient part of a clinical study? unknown.

• Brand Name: VIPER2 5MM SELF DRILLING TAP,
• Common Device Name: TAP, BONE
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8244937
• Report Number: 1526439-2019-51228
• Device Sequence Number: 1912406
• Product Code: HWX
• UDI-Device Identifier: 10705034214078
• UDI-Public: (01)10705034214078
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: 286715500
• Device Catalogue Number: 286715500
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1