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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PCH,BSKT,DCKBL,UPBTR,1.5MM; ACCESSORIES,ARTHROSCOPIC

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SMITH & NEPHEW, INC. PCH,BSKT,DCKBL,UPBTR,1.5MM; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Catalog Number 012014
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/12/2015
Event Type  malfunction  
Manufacturer Narrative
Visual assessment confirmed the reported complaint of breakage.The upper jaw has broken from the shaft.The lug area of the upper jaw has also broken.Further examination using a stereo microscope confirmed that the cutting edge has been filed flat.A dull cutting edge such as this would require excessive forces to cut.Per the ifu "as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges".It has been determined that the device has been repaired in a manner inconsistent with current smith & nephew practice causing the reported failure.No root cause related to the manufacturing process can be established.No further investigation is warranted at this time.
 
Event Description
It was reported via a voluntary medwatch that during a procedure the entire jaw broke off and the jaw fell into the patient.The broken piece was retrieved by the surgeon and they are confident nothing was left in the patient.They were able to complete the procedure with a backup device.There were no patient complications reported as a result of this event.
 
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Brand Name
PCH,BSKT,DCKBL,UPBTR,1.5MM
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 Key5975318
MDR Text Key55873687
Report Number1219602-2016-01007
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/24/2015
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 Number012014
Device Lot NumberL7700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2015
Initial Date Manufacturer Received 02/24/2015
Initial Date FDA Received09/23/2016
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 Reuse
Patient Sequence Number1
Patient Age57 YR
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