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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEWDEAL SAS DEVICE FOR NAIL FIXATION N/A

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NEWDEAL SAS DEVICE FOR NAIL FIXATION N/A Back to Search Results
Catalog Number 519110ND
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
Event Type  malfunction  
Manufacturer Narrative
To date the device involved in the reported incident has not been received for evaluation. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
It was reported by a company representative on behalf of the physician that on (b)(6) 2018 a 519110nd device for nail fixation was cracked around the base of the metal post that holds the nail in place. There was a 10 minute delay in surgery. No impact to the patient was noted and the doctor was able to complete the procedure.
 
Manufacturer Narrative
Investigation completed on 09mar2018. The product not returned therefore investigation for root cause cannot be performed. However, review and comparison of surgical technique show improper gesture that might cause degradation of the support device near the reception axis (this assembly was not provided for being impacted). In conclusion, complaint is not verified.
 
Manufacturer Narrative
The device was returned to the manufacturer for physical evaluation. Failure analysis confirmed the incident but could not determine the root cause. However, review and comparison of surgical technique show improper gesture that might cause degradation of the support device near the reception axis (this assembly was not provided for being impacted). Review of dhr does not show any anomaly. Complaint is verified.
 
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Brand NameDEVICE FOR NAIL FIXATION
Type of DeviceN/A
Manufacturer (Section D)
NEWDEAL SAS
97 allee alexandre borodine
97 allee alexandre borodine
saint priest 69800
FR 69800
MDR Report Key7276747
MDR Text Key100459970
Report Number9615741-2018-00015
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K091788
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number519110ND
Device Lot NumberFE4J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/16/2018
Is This a Reprocessed and Reused Single-Use Device? No

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