MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 TAP, CANNULATED, SELF-DRILLING; TAP, BONE

Catalog Number	286715500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.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
There are 100+ items placed on dc orthokit quarantine due to breakages, functional tests failures.Thirty eight pertain to depuy spine products.In all cases no data available if any injures or adverse events.No information about surgery, delays, patient related data.Only product code/lot description and breakage definition is available.(b)(4).
Additional Manufacturer Narrative
The viper2 5mm self drilling tap was returned for evaluation.Visual inspection revealed that the instruments distal tip was fractured.Review of the device history record identified no issues during the manufacturing or release of the product that could have contributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A review of the complaint trend analysis was performed and no systemic trend was identified as a result of the analysis.The root cause cannot be positively identified however the investigation found evidence of wear and tear on the instrument.It is possible that the device failed as a result of device age/use or unanticipated forces being applied to the distal tip.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 have been observed, 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 TAP, CANNULATED, SELF-DRILLING
• Common Device Name: TAP, BONE
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6663995
• Report Number: 1526439-2017-10511
• Device Sequence Number: 72564
• Product Code: HWX
• UDI-Device Identifier: 10705034214078
• UDI-Public: 10705034214078
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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: Physician
• Device Catalogue Number: 286715500
• Device Lot Number: NG34084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Initial Date Received by Manufacturer: 06/08/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 06/23/2017
• Supplement Report FDA Received Date: 08/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1