MAUDE Adverse Event Report: NEWDEAL SAS BOLD SCREW DIAM 3MM LG 14MM

Catalog Number 111014ND

Device Problems Device Markings/Labelling Problem (2911); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 03/03/2016

Event Type  malfunction  

Event Description

It was reported the print of the lot number on the bold screw is not clear.The issue was found during distributor inspection.The product was not in contact with a patient.No patient injury is alleged.There was no delay of surgery due to the product problem.

Manufacturer Narrative

Integra has completed their internal investigation on 12apr2016.The investigation activities included: methods: evaluation of actual device.Review of device history records.Review of complaint history.Results: the product was returned on 08th april 2016.The item involved is pn 111014nd lot fhkj manufactured on 1st december 2015.After the review of the dhr, (b)(4).Conclusion: we performed a visual inspection of the returned device with wrong marking and products of the same lot in our inventory.The root cause is a failure on the marking laser by the supplier.Further investigations concerning the marking laser of the supplier will permit us to determine the primary root cause.The risk is acceptable with an update of the risk analysis and monitoring similar cases.Non-conformance was initiated to determine the origin of the issue linked to this complaint.

• Brand Name: BOLD SCREW DIAM 3MM LG 14MM
• Type of Device: BOLD
• Manufacturer (Section D): NEWDEAL SAS; 97 allee alexandre borodine; 97 allee alexandre borodine; saint priest 69800 ; FR 69800
• Manufacturer (Section G): NEWDEAL SAS; 97 allee alexandre borodine; parc tech de laporte des alpes; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5515102
• MDR Text Key: 41041316
• Report Number: 9615741-2016-00016
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K011262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111014ND
• Device Lot Number: FHKJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1