MAUDE Adverse Event Report: NEWDEAL SAS BOLD SCREW DIAM. 3MM LG 18MM

Catalog Number 111018ND

Device Problems Delivered as Unsterile Product (1421); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/08/2015

Event Type  malfunction  

Event Description

It was reported there was confusion between sterile and non-sterile products during a procedure.During surgery, the surgeon requested a size 18mm bold 3.0mm screw to fix an osteotomy.He was unknowingly handed a screw from a non-sterile packet which he implanted.When it was spotted that the screw was non-sterile, he decided to remove the screw and theatre staff were forced to open several newdeal forefoot v1 sets in order to find a sterile 18mm screw to implant.This resulted in 15 minutes increase in surgery time with surgical field open while they searched for a sterile screw.Although the product was in contact with the patient, no patient injury is alleged.The hospital carries both sterile and non-sterile stock, as they are currently transitioning from non-sterile to sterile.

Manufacturer Narrative

Complementary information received on (b)(6) 2015: the surgeon has confirmed that as yet there has been no report of infection-like symptoms from the patient.Integra has completed their internal investigation on (b)(6) 2015.The investigation activities included: methods: review of device history records.Review of complaint history.Results: a review of the device history records cannot be performed as no lot number was provided to newdeal.A review of the complaint system was performed.This is the third incident reported to newdeal about implantation of a non-sterile implant (without sterilization) for the past two years.It is the first for bold® screw.During the same time period, (b)(4) non-sterile bold® screws were sold.The complaint rate for this kind of incident during the stated time period is (b)(4) percent.As no lot number was provided, no lot failure rate can be done.Conclusion: given the description of the event and the observations made during investigation, the root cause cannot be determined.No anomaly was observed during documentary investigation where design and labelling specifications, quality records and risk analysis were reviewed.Risk analysis will be updated.No failure analysis can be performed as no product was returned and concerned lot number was not provided to newdeal.

• Brand Name: BOLD SCREW DIAM. 3MM LG 18MM
• 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: 5125584
• MDR Text Key: 27646981
• Report Number: 9615741-2015-00048
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• PMA/PMN Number: K011946
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Dental Hygienist
• Type of Report: Followup
• Report Date: 09/08/2015

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: Health Professional
• Device Catalogue Number: 111018ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1