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U.S. Department of Health and Human Services

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

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DEPUY-SYNTHES SPINE VIPER2 CANNUALATED AWL Back to Search Results
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
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.
 
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.
 
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Brand NameVIPER2 CANNUALATED AWL
Type of DeviceAWL
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 Key6824488
MDR Text Key192239127
Report Number1526439-2017-10706
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received08/28/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number286715210
Device Catalogue Number286715210
Device Lot NumberNG41908
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/31/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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