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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR RCI 8X35MM 2.0 CANN. STER SCREW, FIXATION, BONE

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SMITH & NEPHEW, INC. SCR RCI 8X35MM 2.0 CANN. STER SCREW, FIXATION, BONE Back to Search Results
Model Number 7209411
Device Problem Manufacturing, Packaging or Shipping Problem
Event Date 11/07/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that during acl reconstruction surgery, the 8x35mm was opened but it was a 9x35mm in the packaging. The device was used on patient. A backup device was available to complete the procedure with no significant delay or patient injuries. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.

 
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Brand NameSCR RCI 8X35MM 2.0 CANN. STER
Type of DeviceSCREW, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin , TX 78735
5123913905
MDR Report Key9390517
Report Number1219602-2019-01507
Device Sequence Number1
Product CodeHWC
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/28/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number7209411
Device Catalogue Number7209411
Device LOT Number2029478
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/04/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/22/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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