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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA PAC 1.2; PASSER
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SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA PAC 1.2; PASSER Back to Search Results
Model Number 72202799
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/08/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the 2.7 pin broke off in the patient at the 75 mark, the pin was retrieved.No patient injury was reported.
 
Additional Manufacturer Narrative
Examination was not possible, as the device has not been returned.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.
 
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Brand Name
ENDOBUTTON CL ULTRA PAC 1.2
Common Device Name
PASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
MDR Report Key7267111
Report Number1219602-2018-00212
Device Sequence Number2378267
Product Code HWQ
UDI-Device Identifier03596010657626
UDI-Public(01)03596010657626(17)221128(10)50696836
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K920621
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date (Section B) 03/20/2018
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 Expiration Date11/28/2022
Device Model Number72202799
Device Catalogue Number72202799
Device Lot Number50696836
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 02/08/2018
Supplement Date Received by Manufacturer03/19/2018
Initial Report FDA Received Date02/13/2018
Supplement Report FDA Received Date03/20/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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