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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ADSON DISSECT HK BLT 7.75"; HOOK, SURGICAL, GENERAL & PLAS
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TELEFLEX MEDICAL ADSON DISSECT HK BLT 7.75"; HOOK, SURGICAL, GENERAL & PLAS Back to Search Results
Catalog Number SURGICAL UNKNOWN
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the item listed is the closest based on the customer description as no model number is given and said it is at least 6 years old.During a surgical procedure on the spine the tip of nerve retractor fell off into the cavity.There was no injury to the patient and the tip was extracted with no issue.
 
Manufacturer Narrative
Qn#(b)(4).The device was discontinued greater than 10 years ago which exceeds our document retention period.(1) sample of 185700 was received for evaluation.This product was discontinued >10 years ago and has exceeded it's expected life.Visual evaluation of the tip noted a fracture plan suggestive of sheering force.No corrosion or deficiencies of the metal were observed.No further evaluation is required.
 
Event Description
It was reported that the item listed is the closest based on the customer description as no model number is given and said it is at least 6 years old.During a surgical procedure on the spine the tip of nerve retractor fell off into the cavity.There was no injury to the patient and the tip was extracted with no issue.
 
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Brand Name
ADSON DISSECT HK BLT 7.75"
Type of Device
HOOK, SURGICAL, GENERAL & PLAS
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8358430
MDR Text Key137055052
Report Number3011137372-2019-00055
Device Sequence Number1
Product Code HNL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/01/2019
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 NumberSURGICAL UNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2019
Initial Date Manufacturer Received 02/01/2019
Initial Date FDA Received02/21/2019
Supplement Dates Manufacturer Received03/01/2019
Supplement Dates FDA Received03/25/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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