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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T7 HOLDING SLEEVE; GUIDE, SURGICAL, INSTRUMENT
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SMITH & NEPHEW, INC. T7 HOLDING SLEEVE; GUIDE, SURGICAL, INSTRUMENT Back to Search Results
Catalog Number 71174988
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/23/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during surgery the tip of driver broke off in screw head.The tip was retrieved.It is unknown if there was a backup device available or a delay.
 
Additional Manufacturer Narrative
The associated complaint devices were not returned.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.
 
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Brand Name
T7 HOLDING SLEEVE
Common Device Name
GUIDE, SURGICAL, INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8634426
Report Number1020279-2019-02030
Device Sequence Number1975298
Product Code FZX
UDI-Device Identifier00885556500699
UDI-Public00885556500699
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/03/2019
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 Number71174988
Initial Date Received by Manufacturer 05/02/2019
Supplement Date Received by Manufacturer05/02/2019
Initial Report FDA Received Date05/22/2019
Supplement Report FDA Received Date10/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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