• 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 PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS; FORCEPS

  • 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 PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS; FORCEPS Back to Search Results
Model Number 03.118.007
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2021
Event Type  malfunction  
Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
 
Event Description
It was reported that on (b)(6) 2021, during an unknown procedure the drill sleeve top hat broke, retrograde/antegrade femoral nail (rafn) entry reamer is dull, drive adaptor with qc for 5.0mm schanz screws and drive adaptor with qc for 6.0 schanz screws were stripped.The percutaneous depth gauge, depth gauge for locking screws, and depth gauge for cortex screws were bent.It is unknown how the procedure was completed.There was a surgical delay of fifteen (15) minutes.This report involves one (1) percutaneous depth gauge for 2.7mm screws.This is report 5 of 8 for (b)(4).This product complaint, (b)(4), is related to (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PERCUTANEOUS DEPTH GAUGE FOR 2.7MM SCREWS
Type of Device
FORCEPS
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
WERK BALSTHAL (CH)
dornacherstrasse 20
balsthal 4710
SZ   4710
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key11413272
MDR Text Key246218207
Report Number2939274-2021-01165
Device Sequence Number1
Product Code HTD
UDI-Device Identifier10886982073365
UDI-Public(01)10886982073365
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 company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/09/2021
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 Number03.118.007
Device Catalogue Number03.118.007
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2021
Initial Date FDA Received03/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-