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U.S. Department of Health and Human Services

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

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NEWDEAL SAS BOLD SCREW DIAM. 3MM LG 18MM Back to Search Results
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.
 
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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 Key5125584
MDR Text Key27646981
Report Number9615741-2015-00048
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K011946
Number of Events Reported1
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 Number111018ND
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/02/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/20/2015
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 Number1
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