Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. G2 P/S ART TR SZ3-4 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  • 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. G2 P/S ART TR SZ3-4 9MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number 71430815
Device Problem Flaked (1246)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that, during the set up for a tka surgery, a genesis ii posterior stabilizing articular trial size 3-4 9mm was noticed to be chipped.Surgery was performed, with the same device.Patient was not harmed as consequence of this problem.It is unknown if any delay occurred as a consequence of this problem.
 
Manufacturer Narrative
Internal complaint reference case-(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that, during the set up for a tka surgery, a genesis ii posterior stabilizing articular trial size 3-4 9mm was noticed to be chipped.Surgery was performed, with the same device.Patient was not harmed as consequence of this problem.It is unknown if any delay occurred as a consequence of this problem.
 
Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
G2 P/S ART TR SZ3-4 9MM
Type of Device
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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 Key13388673
MDR Text Key285171807
Report Number1020279-2022-00364
Device Sequence Number1
Product Code LXH
UDI-Device Identifier03596010213402
UDI-Public03596010213402
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/02/2022
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 Model Number71430815
Device Catalogue Number71430815
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/10/2022
Initial Date FDA Received01/28/2022
Supplement Dates Manufacturer Received03/01/2022
Supplement Dates FDA Received03/02/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-