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

Model Number	286715600
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, a psf (posterior spinal fusion) treating lumbar spinal canal stenosis was performed.While the tap (286715600) was being used for making a burr hole, the threads broke off in the burr hole.The surgeon had difficulty removing the fragment and left it in the burr hole.The procedure was delayed by sixty (60) minutes.The surgeon commented that the bone quality was robust.This report is for one (1) viper2 6mm self drilling tap.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint #: (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: investigation summary background: it was reported that this was a psf (posterior spinal fusion) treating lumbar spinal canal stenosis on jan.27, 2020.While the the tap (286715600) was being used for making a burr hole, the threads broke off in the burr hole.Because it seemed difficult to remove the fragment, the surgeon left it in the burr hole.The procedure was delayed by 60 minutes.The surgeon commented that the bone quality was robust.This complaint involves one (1) device.Investigation flow: damage.Visual inspection: the viper2 6mm self drilling tap (part # 286715600/ lot #ng35304) was received at us cq.The tap was broken transversely proximal to where the threads started.No fragments were returned, only the base shaft of the device was received.The complaint condition of embedded device could not be confirmed as no x-rays were provided to show the alleged embedded condition.The overall complaint was confirmed due to the identified broken condition.Conclusion: the overall complaint was confirmed for the received viper2 6mm self drilling tap as the tap was broken.Although no definitive root-cause can be determined its possible the device experienced unintended forces.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.H3, h4, h6: a review of the device history record.Device history lot: a review of the receiving inspection (ri) for viper2 6mm self drilling tap was conducted identifying that lot number ng35304 was released in a single batch.Batch1: lot qty of 43 units were released on 07 nov 2012 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history batch null, device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.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: 9707705
• Report Number: 1526439-2020-00546
• Device Sequence Number: 3475139
• Product Code: HWX
• UDI-Device Identifier: 10705034214092
• UDI-Public: (01)10705034214092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2020

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: NG35304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 01/26/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 04/01/2020
• 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 Weight: 103