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: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH
  • 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 DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS; GAUGE,DEPTH Back to Search Results
Model Number 319.006
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
Exact date is unknown.Initial reporter is synthes sales representative.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.Product was not returned.Device history records review could not be completed without lot number.Based on the information available, it has been determined that no corrective and 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.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 an unknown date, the gray knob on the non-measuring end of the depth gauge in the 2.4/2/7 variable angel locking compression plate (lcp) forefoot midfoot (ffmf) set fell off when the surgeon went to measure the length of the unknown screw.There was nothing to pull against when trying to measure screw lengths.No parts went missing and the surgery was delayed for approximately three (3) minutes until another depth gauge was pulled out from another set.The depth gauge would "stick" when the surgeon tried to measure and said that it was not working properly and difficult to use.The surgeon completed the surgery with the "sticking" depth gauge and there was no further delay.Procedure outcome is unknown.No patient consequence reported.Concomitant devices: screw (part unknown, lot unknown, quantity 1).This report is for one (1) depth gauge.This is report 1 of 2 for (b)(4).
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6: a review of the device history record.Part number: 319.006 , synthes lot number: ft00417 , supplier lot number: n/a , release to warehouse date: 15 mar 2017 , expiration date: n/a , supplier: (b)(4).No ncrs were generated during production.Device history batch null, device history reviewreview of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.H3, h6: investigation summary investigation background: modified event description: it was reported that on an unknown date, the gray knob on the non-measuring end of the depth gauge in the 2.4/2/7 variable angel locking compression plate (lcp) forefoot midfoot (ffmf) set fell off when the surgeon went to measure the length of the unknown screw.There was nothing to pull against when trying to measure screw lengths.No parts went missing and the surgery was delayed for approximately three (3) minutes until another depth gauge was pulled out from another set.The depth gauge would "stick" when the surgeon tried to measure and said that it was not working properly and difficult to use.The surgeon completed the surgery with the "sticking" depth gauge and there was no further delay.Procedure outcome is unknown.No patient consequence reported.Concomitant devices: screw (part unknown, lot unknown, quantity 1).This complaint involves two (2) devices.Investigation flow: visual/damage.Visual inspection: the depth gauge for 2.0mm and 2.4mm screws (p/n 319.006 lot ft00417) was received with a missing dowel pin (es0003-76).Due to the missing dowel pin, the handle is disassembled from the slider.The device failure/defect of missing component was identified during the investigation and is related to the reported complaint condition of a broken/fallen off handle.Dimensional inspection: dimensional inspection was not performed due to missing components and the condition was visually confirmed.Document/specification review: during the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.Conclusion: the complaint condition of broken/fallen off handle is confirmed for the depth gauge for 2.0mm and 2.4mm screws (p/n 319.006 lot ft00417) as the handle is disassembled from the slider due to the missing dowel pin.No definitive root cause could be determined for the missing dowel pin.It is possible that the unintended forces/rough handling during device use may have caused the dowel pin to break/fall off and be misplaced.During this investigation no product design or manufacturing issues were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS
Type of Device
GAUGE,DEPTH
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8322803
MDR Text Key137519239
Report Number2939274-2019-56378
Device Sequence Number1
Product Code HTJ
UDI-Device Identifier10886982189943
UDI-Public(01)10886982189943
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 01/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number319.006
Device Catalogue Number319.006
Device Lot NumberFT00417
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Date Manufacturer Received09/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-