• 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. TWINFIX TI 5.0 ULTRABRAID; STAPLE, 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. TWINFIX TI 5.0 ULTRABRAID; STAPLE, FIXATION, BONE Back to Search Results
Model Number 72200755
Device Problems Detachment Of Device Component (1104); Connection Problem (2900)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/21/2018
Event Type  malfunction  
Event Description
It was reported that while using a twinfix titanium 5.0 ultrabraid and doing the knot, the thread came out from the anchor.
 
Manufacturer Narrative
Due to no product return the complaint could not be confirmed.Definitive conclusions, accurate investigation and evaluation are not possible without product to evaluate.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
TWINFIX TI 5.0 ULTRABRAID
Type of Device
STAPLE, FIXATION, BONE
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 west william cannon drive
austin, TX 78735
MDR Report Key7393496
MDR Text Key104421444
Report Number1219602-2018-00396
Device Sequence Number1
Product Code JDR
UDI-Device Identifier03596010577986
UDI-Public(01)03596010577986(17)221219(10)50703442
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K972326
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 05/14/2018
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 Expiration Date12/19/2022
Device Model Number72200755
Device Catalogue Number72200755
Device Lot Number50703442
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/21/2018
Initial Date FDA Received04/03/2018
Supplement Dates Manufacturer Received05/09/2018
Supplement Dates FDA Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-