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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 Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6). One 2. 4 mm drill tipped passing pin was returned for evaluation. Visual assessment of the device confirmed the reported breakage. The passing pin has broken approximately. 883 from its drill tipped end. The tip is damaged in a circular manner at the break area. The corresponding shaft is bent and is missing a segment of material at the location of the break. The shaft of the device is also damaged in a circular manner at several locations along its length. The condition of the device indicates it was subjected to excessive forces during use. Per the device instructions for use, under precautions: ¿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¿. No root cause related to the manufacturing process can be established.
 
Event Description
It was reported that, during an acl reconstruction procedure, the drill tip guide wire broke. The broken piece was removed from the body with a grasper. The surgery had been finished with the same device but was extended for 5 min more as consequence of the alleged malfunction. The patient, who had a hard bone quality, did not suffer any adverse event.
 
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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
5123585706
MDR Report Key8531974
MDR Text Key142615100
Report Number1219602-2019-00437
Device Sequence Number1
Product Code HWQ
UDI-Device Identifier03596010374691
UDI-Public03596010374691
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
Type of Report Initial
Report Date 04/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number014396
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/29/2019
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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