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

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY

  • 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
 

WRIGHTS LANE SYNTHES USA PRODUCTS LLC SCREW INSERTER ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Model Number 03.037.025
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4). Event year is reported as 2021; however exact date of event is unknown. Reporter is a j&j representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that on unknown date, patient underwent an orthopedic surgery. It was noted that the triple trocar for tfna head element would not fully connect between the 3 different trocars. During the surgery, the inner connecting screw for the lag screw insertion handle would not fully seat. There was a one-minute of surgical delay noted. There were no fragments generated noted. It is unknown if the procedure was successfully completed. There were no patient consequences. This complaint involves five (5) devices. This report is for (1)screw inserter. This report is 4 of 8 for (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSCREW INSERTER
Type of DeviceROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BETTLACH (CH)
muracherstrasse 3
bettlach 2544
SZ 2544
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12460247
MDR Text Key271039450
Report Number2939274-2021-05349
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131548
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number03.037.025
Device Catalogue Number03.037.025
Device Lot NumberL924789
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/13/2021 Patient Sequence Number: 1
Treatment
3.2MM WIRE GUIDE SLEEVE; GUIDE SLEEVE YELL; HELICAL BLADE/SCREW COUPLING SCREW; TROCAR YELL; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA; UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA
-
-