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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. AWL-DILATOR, TWINFIX ULTRA, 4.5MM; ACCESSORIES, ARTHROSCOPIC

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SMITH & NEPHEW, INC. AWL-DILATOR, TWINFIX ULTRA, 4.5MM; ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 72202633
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6).A visual inspection of the device confirmed the reported complaint of the tip breaking off.The tip was not returned for examination.The proximal end of the handle is heavily damaged.This condition is consistent with excessive force being applied during use.There are no indications that would suggest the device did not meet product specifications upon release into distribution.
 
Event Description
It was reported the twinfix awl dilator tip broke off in the joint.Another device was available for use.No patient injury or other complications were reported.
 
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Brand Name
AWL-DILATOR, TWINFIX ULTRA, 4.5MM
Type of Device
ACCESSORIES, ARTHROSCOPIC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
150 minuteman road
andover, MA 01810
5123585706
MDR Report Key5960938
MDR Text Key55380643
Report Number1219602-2016-00689
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/01/2016
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 Number72202633
Device Lot Number50496350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/01/2016
Initial Date FDA Received09/19/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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