• 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. FEMORAL HEAD/NECK IMPACTOR PROSTHESIS,HIP,SEMI-CNSTRND,UNCEMENTED,METAL/PLYMR,NON-POROUS,CA-PHSPHAT

  • 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. FEMORAL HEAD/NECK IMPACTOR PROSTHESIS,HIP,SEMI-CNSTRND,UNCEMENTED,METAL/PLYMR,NON-POROUS,CA-PHSPHAT Back to Search Results
Model Number 71360093
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 10/06/2020
Event Type  malfunction  
Manufacturer Narrative
The associated device, intended for use in treatment, was returned and evaluated. A visual inspection of the returned device confirmed the stated failure. The impactor tip of the device is missing. The device was manufactured in 2019 and shows signs of extensive use. A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. At this time, we do not have 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.   based on this investigation, the need for corrective action is not indicated. Should 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.
 
Event Description
It was reported that during an office inspection it was found that the tip to the impactor is missing. No case involved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFEMORAL HEAD/NECK IMPACTOR
Type of DevicePROSTHESIS,HIP,SEMI-CNSTRND,UNCEMENTED,METAL/PLYMR,NON-POROUS,CA-PHSPHAT
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
1450 brooks road
memphis, TN 38116
MDR Report Key10780303
MDR Text Key214413012
Report Number1020279-2020-06080
Device Sequence Number1
Product Code MEH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K113789
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number71360093
Device Catalogue Number71360093
Device Lot Number19HM07028
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-