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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. DRILL TIP GUIDE WIRE,2.4MM PASSER

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SMITH & NEPHEW, INC. DRILL TIP GUIDE WIRE,2.4MM PASSER Back to Search Results
Catalog Number 014396
Device Problems Break (1069); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/07/2018
Event Type  malfunction  
Event Description
It was reported that the wire broke off. Broken piece was removed from patient. No patient injury or delay was reported.
 
Manufacturer Narrative
One 2. 4 drill tip guide wire was returned for evaluation. Visual assessment of the guide wire confirmed the reported breakage. The guide wire is bent at the break area. A major area of abrasion is located at the breakage. The condition of the device indicates the drill came in contact with the guide wire when over drilling causing the observed damage. Drilling over a bent guide wire would require the use of excessive force. Per the devices ifu ¿as with any surgical instrument, careful attention should be made to assure that excessive force is not placed on the instrument. Excessive forces applied to the instrument can result in failure¿.
 
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Brand NameDRILL TIP GUIDE WIRE,2.4MM
Type of DevicePASSER
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
5123485706
MDR Report Key8061305
MDR Text Key127071931
Report Number1219602-2018-01520
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K920621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number014396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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