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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. G2 INS SPAC TR SZ7-8 13MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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SMITH & NEPHEW, INC. G2 INS SPAC TR SZ7-8 13MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Catalog Number 71430230
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Injury (2348)
Date of Event 05/12/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the insert trial broke during removal.Smith&nephew backup device was available to completed the procedure.Delay less or equal than 30 minutes reported.It is unknown if all pieces were retrieved.
 
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Brand Name
G2 INS SPAC TR SZ7-8 13MM
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key10127544
Report Number1020279-2020-02148
Device Sequence Number3816674
Product Code LXH
UDI-Device Identifier03596010211880
UDI-Public3596010211880
Combination Product (Y/N)N
Initial Reporter StateSC
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 Physician
Type of Report Initial,Followup
Report Date (Section B) 10/29/2020
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 Number71430230
Device Lot Number12JB00923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2020
Initial Date Received by Manufacturer 05/12/2020
Supplement Date Received by Manufacturer10/26/2020
Initial Report FDA Received Date06/08/2020
Supplement Report FDA Received Date10/29/2020
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; Required Intervention;
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