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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FIXATION BOLT WRENCH
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SMITH & NEPHEW, INC. FIXATION BOLT WRENCH Back to Search Results
Catalog Number 102911
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/24/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that during procedure, surgeon was tightening combi bolt and one side of the wrench teeth broke off.No more information provided yet.
 
Additional Manufacturer Narrative
This complaint has been re-evaluated for mdr reporting.Therefore, it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.
 
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Brand Name
FIXATION BOLT WRENCH
Common Device Name
WRENCH
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8824199
Report Number1020279-2019-02736
Device Sequence Number14162766
Product Code HXC
UDI-Device Identifier03596010031839
UDI-Public03596010031839
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 Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/08/2019
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 Number102911
Initial Date Received by Manufacturer 06/24/2019
Supplement Date Received by Manufacturer06/24/2019
Initial Report FDA Received Date07/24/2019
Supplement Report FDA Received Date11/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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