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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. STONECUTTER ACR,EP-1,5.5 DSPL SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. STONECUTTER ACR,EP-1,5.5 DSPL SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205331
Device Problem Peeled/Delaminated (1454)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/1901
Event Type  malfunction  
Manufacturer Narrative
Three 5. 5 ep-1 stonecutter burrs were returned for evaluation. Visual assessment of the burrs showed no evidence of debridement/shedding on the inner burr or outer sheath. Functional inspection was performed and the inner burrs rotated freely within the outer sheaths, no friction was felt in the unloaded condition. The reported shedding could not be confirmed. No root cause related to the manufacture of the device can be established. No further investigation is warranted at this time.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the blade was shedding during the procedure. A backup device was available to complete the procedure without patient impact.
 
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Brand NameSTONECUTTER ACR,EP-1,5.5 DSPL
Type of DeviceSAW, POWERED, AND ACCESSORIES
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
james gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7051507
MDR Text Key114873218
Report Number1219602-2017-01457
Device Sequence Number1
Product Code HAB
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
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/15/2022
Device Model Number7205331
Device Catalogue Number7205331
Device Lot Number50652938
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/15/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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