MAUDE Adverse Event Report: DEPUY-SYNTHES SPINE VIPER2 CANNUALATED AWL

Model Number 286715210

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2017

Event Type  malfunction  

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.Awaiting sample: 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.Device not yet returned for evaluation.

Event Description

During inspection on (b)(6) 2017 orthokit specialist found out 2 devices with damage: code 286725420, lot gm3982501 the introduction jammed inserter guide wire screw (holder).Code 286715210, lot ng41908 broke off one of the three teeth.

Manufacturer Narrative

Visual examination of the returned device found a fracture located at the distal tip.Optical imaging revealed a static failure across the surface of the fracture.Hardness testing was also performed.Device was within specified guidelines.A trend analysis was conducted.No emerging trends were found requiring further actions.A definitive root cause cannot be positively determined from the sample and the information provided.However, based on the fracture analysis evaluation, the likely cause of the tip breakage is static failure across the surface of the device.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: VIPER2 CANNUALATED AWL
• Type of Device: AWL
• Manufacturer (Section D): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY-SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jason busch ; 325 paramount drive; raynham, MA 02767 ; 5088808201
• MDR Report Key: 6824488
• MDR Text Key: 83787013
• Report Number: 1526439-2017-10706
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 10705034214009
• UDI-Public: (01)10705034214009
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

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
• Device Operator: Physician
• Device Model Number: 286715210
• Device Catalogue Number: 286715210
• Device Lot Number: NG41908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1