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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. COMPASS UNIVERSAL HINGE; PIN, FIXATION, THREADED
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SMITH & NEPHEW, INC. COMPASS UNIVERSAL HINGE; PIN, FIXATION, THREADED Back to Search Results
Catalog Number 71060001
Health Effect - Clinical Codes No Information (3190); No Code Available (3191)
Date of Event 10/06/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that when this item was taken to surgery, it was discovered that one of the two t-bolts was missing.Hospital improvised 16mm bolt to substitute & continued case as normal.Surgical extension > 30 minutes.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).
 
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Brand Name
COMPASS UNIVERSAL HINGE
Common Device Name
PIN, FIXATION, THREADED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6968065
Report Number1020279-2017-00895
Device Sequence Number1300952
Product Code JDW
UDI-Device Identifier03596010328212
UDI-Public03596010328212
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K994143
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) 12/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Catalogue Number71060001
Device Lot Number15MM04288A
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/06/2017
Supplement Date Received by Manufacturer10/06/2017
Initial Report FDA Received Date10/23/2017
Supplement Report FDA Received Date12/11/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization;
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