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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

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SMITH & NEPHEW, INC. TWIST DRILL FLEX CRVD FOR 2.3 SA; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE Back to Search Results
Catalog Number 72203160
Device Problems Break (1069); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported while the surgeon was preparing the hole for the anchor, the drill snagged against the metal cannula and filings sheared off into the joint.The metal shavings were retrieved and removed from the joint with the use of a grasper.
 
Manufacturer Narrative
Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was performed which confirmed no inconsistencies.No further investigation is warranted at this time.
 
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Brand Name
TWIST DRILL FLEX CRVD FOR 2.3 SA
Type of Device
FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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 w. william cannon
austin, TX 78735
MDR Report Key6617285
MDR Text Key76968666
Report Number1219602-2017-00576
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K102660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number72203160
Device Lot Number50656837
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/11/2017
Initial Date FDA Received06/07/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/28/2017
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
Patient Sequence Number1
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