MAUDE Adverse Event Report: NEWDEAL SAS K WIRE DIAM 1.6MM LG 200MM 1 SHARP END BLUNT; QUIX

Catalog Number 115516ND

Device Problems Device Packaging Compromised (2916); Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported; some of the devices were not packed well and were damaged.The sterile barrier was breached in shipping.The event was discovered while unpacking the shipment of devices.There was no patient contact or injury.

Manufacturer Narrative

The device involved in the reported incident has been returned.The device evaluation is in progress.The result of the device evaluation will be reported in a follow up mdr submission.

Manufacturer Narrative

Integra has completed their internal investigation.Eval of actual device, review of complaint history, results: on december 9, 2014, the odc shipped a container that was improperly packed.Individual components were not packaged in a separate polyethylene bag, insufficient dunnage was added to the shipper to prevent the movement of product and the package was shipped to the wrong address.A design history record review was not required since this complaint involved a shipping issue and not the form.Fit, function or performance of individual product(s).A review of complaints history found two (2) other customer complaints associated with damaged items that were traceable to improper packaging of product by the odc.Conclusion: the root cause for this complaint was a break down in human performance involving the packaging process of instrument sets and individually packaged instruments and implants.This was considered an isolated incident and no further corrective actions are required.Integra lifesciences continues to monitor the field for all issues regarding the packaging and distribution of product from the odc, and further action will be taken if any actionable trends are identified.

• Brand Name: K WIRE DIAM 1.6MM LG 200MM 1 SHARP END BLUNT
• Type of Device: QUIX
• Manufacturer (Section D): NEWDEAL SAS; saint priest 69800 ; FR 69800
• Manufacturer Contact: maria leonard ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362341
• MDR Report Key: 4398967
• MDR Text Key: 5302873
• Report Number: 9615741-2014-00069
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 115516ND
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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