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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC
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SMITH & NEPHEW, INC. ARTHROPIERCE 45 DEG RIGHT; ACCESSORIES,ARTHROSCOPIC Back to Search Results
Model Number 7209497
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/24/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the movable bite broke inside the patient.Piece was recovered.There was no delay or patient injury 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
ARTHROPIERCE 45 DEG RIGHT
Common Device Name
ACCESSORIES,ARTHROSCOPIC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
MDR Report Key7252880
Report Number1219602-2018-00201
Device Sequence Number1215810
Product Code NBH
UDI-Device Identifier03596010474520
UDI-Public(01)03596010474520(10)50619167
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 03/09/2018
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 Model Number7209497
Device Catalogue Number7209497
Device Lot Number50619167
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 01/24/2018
Supplement Date Received by Manufacturer03/08/2018
Initial Report FDA Received Date02/08/2018
Supplement Report FDA Received Date03/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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