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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ORTHOMATCH UNIVERSAL CUT BLOCK
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SMITH & NEPHEW, INC. ORTHOMATCH UNIVERSAL CUT BLOCK Back to Search Results
Catalog Number 71442109
Medical Device Problem Code Connection Problem (2900)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 07/12/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a malfunction has occured in where the cutting block detaches from the attachment and was not holding firmly, it was very loose.
 
Additional Manufacturer Narrative
The device was not evaluated due to no sample was returned for investigation.Investigation results: the associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.Credit cannot be issued for the device.
 
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Brand Name
ORTHOMATCH UNIVERSAL CUT BLOCK
Common Device Name
ORTHOMATCH UNIVERSAL CUT BLOCK
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7715971
Report Number1020279-2018-01383
Device Sequence Number1121368
Product Code JWH
UDI-Device Identifier00885556494356
UDI-Public00885556494356
Combination Product (Y/N)N
Initial Reporter CountrySF
PMA/510(K) Number
K142807
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 10/05/2018
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 Number71442109
Device Lot Number14HAB0005
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 07/12/2018
Supplement Date Received by Manufacturer07/12/2018
Initial Report FDA Received Date07/24/2018
Supplement Report FDA Received Date10/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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