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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR SAW, POWERED, AND ACCESSORIES

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SMITH & NEPHEW, INC. SPADE DRILL BIT FOR 2.9 ANCHOR SAW, POWERED, AND ACCESSORIES Back to Search Results
Catalog Number 72201395
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 05/23/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(6).

 
Event Description

It was reported that item has snapped inside the patient's bone during surgery but due to the depth of the snapped part the surgeon has left the snapped part inside the patient. A backup device was available to complete the procedure with no delay or patient injuries.

 
Manufacturer Narrative

Due to no product return the complaint could not be ultimately confirmed. Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate. No further actions pursued at this time. If objective evidence, relevant information or product becomes available to assist with evaluation, the complaint will certainly be revisited. Information added.

 
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Brand NameSPADE DRILL BIT FOR 2.9 ANCHOR
Type of DeviceSAW, POWERED, AND ACCESSORIES
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
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key7608364
MDR Text Key111846593
Report Number1219602-2018-00747
Device Sequence Number1
Product Code HAB
Combination Product (Y/N)N
PMA/PMN NumberEXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type DISTRIBUTOR,FOREIGN,OTHER,USE
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number72201395
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/20/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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