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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SVC REPL MDU HAND CNTRL PWRMX SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SVC REPL MDU HAND CNTRL PWRMX SAW, POWERED, AND ACCESSORIES Back to Search Results
Model Number 72200616S
Device Problems Overheating of Device (1437); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/12/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference (b)(4).
 
Event Description
It was reported that during a hip arthroscopy procedure, the motor drive unit jammed and stopped working. The shaver was not functioning when attached to the handpiece when it was activated and the handpiece was heating up. The procedure was successfully completed without delay using a back-up device. No patient injury or other complications were reported.
 
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Brand NameSVC REPL MDU HAND CNTRL PWRMX
Type of DeviceSAW, POWERED, AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer (Section G)
SMITH & NEPHEW, INC.
76 s. meridian ave.
oklahoma city OK 73107
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key12695525
MDR Text Key278339352
Report Number1643264-2021-02373
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number72200616S
Device Catalogue Number72200616S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/08/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received11/09/2021
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 Unkown

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