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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENSION GAUGE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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SMITH & NEPHEW, INC. TENSION GAUGE; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE Back to Search Results
Catalog Number 00578907100
Medical Device Problem Code Device Damaged by Another Device (2915)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 10/11/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a malfunction has occurreed.The tension gauge broke during surgery.
 
Additional Manufacturer Narrative
The associated tension gauge was returned and evaluated.A visual inspection of the product confirmed the gauge was broken in half.The broken piece is not returned.The gauge shows signs of significant wear/usage.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should the device or additional information be received, the complaint will be reopened.
 
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Brand Name
TENSION GAUGE
Common Device Name
INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8033199
Report Number1020279-2018-02350
Device Sequence Number1464218
Product Code MDM
UDI-Device Identifier00885556618868
UDI-Public00885556618868
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 12/18/2018
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
Operator of Device Health Professional
Device Catalogue Number00578907100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/19/2018
Initial Date Received by Manufacturer 10/11/2018
Supplement Date Received by Manufacturer10/11/2018
Initial Report FDA Received Date11/02/2018
Supplement Report FDA Received Date12/18/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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