MAUDE Adverse Event Report: NEWDEAL SAS SPIN SCREW LG 12MM STERILE; N/A

Catalog Number 112012SND

Device Problems Device Expiration Issue (1216); Shelf Life Exceeded (1567)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2016

Event Type  malfunction  

Event Description

It was reported an expired screw was implanted.It was reported that customer service discovered that one of the spin in the consignment used during the surgery had an expiry date of august 2015.It was reported there is no patient injury alleged.It was reported the issue did not increase the surgery time.

Manufacturer Narrative

Integra has completed their internal investigation on 29aug2016.The investigation activities included: methods: -review of device history records.-review of complaint history.Results: information collected from the manufacturer: ¿part number 112012snd lot emue was manufactured on september 21st 2010 and (b)(4) parts were released.No anomaly was found.A specific check was done on the copy of the label that is in the dhr.The expiration date is in compliance with newdeal specification (4 years and 11 months after manufacturing date) and on august 2015 in the label.The issue is a distribution-related issue.It is not related to the performance of the product.Including this complaint, 0 complaints of the same nature have been received for the past year (0 complaints / product uses).This is not statistically adverse when compared to the complaint rate for the prior time period (0 complaints / product uses).Conclusion: based on the investigation performed by integra, the complaint reported by the (b)(6) is not confirmed.As per the consignment contract signed between the customer and integra, this is the responsibility of the customer to manage expiry dates.Moreover, regardless of the contract, this is the responsibility of the hospital to check the implant (expiry date included) before implanting it into the patient.

• Brand Name: SPIN SCREW LG 12MM STERILE
• Type of Device: N/A
• 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: 5722673
• MDR Text Key: 48409842
• Report Number: 9615741-2016-00032
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K991477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Dental Hygienist
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 112012SND
• Device Lot Number: EMUE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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