MAUDE Adverse Event Report: DEPUY SYNTHES SPINE VIPER2 APPROXIMATING SET SCREW INSERTER, SELF-RETAINING; DRIVER, PROSTHESIS

Model Number	286735350
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Review of the device history record identified no issues during the manufacturing or release of the product that could be attributed to the problem reported by the customer.The product was released accomplishing all quality requirements.A follow up report will be filed 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
Orthokit specialist checked devices and found next damages: code 286720000 - the thread damage code 286735350 - had the working part of the screwdriver code 286735400 - the failure of the slot code 286745550 - the working part was broken.The date of inspection is (b)(6) 2017 and we accepted this date as date of the event.
Additional Manufacturer Narrative
The x25 approximator was returned for evaluation.Visual inspection revealed that the distal tip of the driver was missing.Optical imaging found evidence of a torsional shear overloading.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 determined however the failure is mostly due to unanticipated torsional loads.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 APPROXIMATING SET SCREW INSERTER, SELF-RETAINING
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 6798145
• Report Number: 1526439-2017-10664
• Device Sequence Number: 1247076
• Product Code: HWR
• UDI-Device Identifier: 10705034214573
• UDI-Public: (01)10705034214573
• 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: Service Personnel
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2017

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 Model Number: 286735350
• Device Catalogue Number: 286735350
• Device Lot Number: GM3423803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Initial Date Received by Manufacturer: 07/26/2017
• Supplement Date Received by Manufacturer: 09/15/2017
• Initial Report FDA Received Date: 08/16/2017
• Supplement Report FDA Received Date: 09/21/2017
• Patient Sequence Number: 1