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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6) SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. ACROMIONIZER,5.5,EP-1,DSPL BL(6) SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 7205327
Device Problem Material Disintegration (1177)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2018
Event Type  malfunction  
Event Description
It was reported that the device put metal shavings into the joint while in use. All the pieces were removed. A backup device was available to complete the procedure with no significant delay and no patient injuries.
 
Manufacturer Narrative
One used 5. 5 mm acromionizer burr was returned for evaluation. Visual assessment of the burr showed a contact point on a section of the inner sheath which coincides with the bronze bushing. Dimensional assessment found the device met print specifications. The burr was shed tested and the reported shedding was confirmed. A re-design the inner burr has been initiated, as part of the re-design the bronze bushing will be replaced by a secondary shrink tubing. This improvement will eliminate this mode of shedding.
 
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Brand NameACROMIONIZER,5.5,EP-1,DSPL BL(6)
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
5123585706
MDR Report Key7797009
MDR Text Key117708198
Report Number1219602-2018-01095
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number7205327
Device Catalogue Number7205327
Device Lot Number50674360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/08/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/13/2017
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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