• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3MMX1000MM BALL TP GDE RD PLATE, FIXATION, BONE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITH & NEPHEW, INC. 3MMX1000MM BALL TP GDE RD PLATE, FIXATION, BONE Back to Search Results
Model Number 71631626
Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Event Description
It was reported that, during surgery, it was noticed that 3mmx1000mm ball tp gde rd went through the sterile package. Surgery was resumed, without any delay, with a back-up device. Patient was not injured as consequence of this problem.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name3MMX1000MM BALL TP GDE RD
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 Key12291559
MDR Text Key265548570
Report Number1020279-2021-06207
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 08/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71631626
Device Catalogue Number71631626
Device Lot Number20LSM0249
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-