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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL19H L 399MM PLATE, FIXATION, BONE

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SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL19H L 399MM PLATE, FIXATION, BONE Back to Search Results
Model Number 71800019
Device Problems Delivered as Unsterile Product (1421); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
Event Type  malfunction  
Manufacturer Narrative
Internal complaint reference number: (b)(4).
 
Event Description
It was reported that during procedure the packaging of the 4. 5mm l-d fem lk pl19h l 399mm was found split and the sterile barrier was compromised. It was noted prior to giving it to the scrub nurse, into the sterile field. There was a s&n back up device of the same configuration available to complete the procedure. There was no delay. No injuries involved.
 
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Brand Name4.5MM L-D FEM LK PL19H L 399MM
Type of DevicePLATE, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11371605
MDR Text Key233242985
Report Number1020279-2021-01555
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K092015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71800019
Device Catalogue Number71800019
Device Lot Number15BM07647
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/22/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/11/2015
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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