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 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
  • 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 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Model Number 02.124.413S
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Code Available (3191)
Event Date 01/01/2019
Event Type  Injury  
Manufacturer Narrative
Additional procodes: hrs, hwc.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A device history record review has been requested.(b)(4).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 during an unknown procedure on (b)(6) 2019, the twelve (12) hole left variable angle (va) condylar plate would not thread into an aiming arm.A ten (10) hole left va condylar plate was used instead.Procedure was successfully completed with a surgical delay of ten (10) minutes.Patient outcome was good.Concomitant devices: screws (part: unknown, lot: unknown, quantity: unknown), aiming arm (part: unknown, lot: unknown, quantity: 1).This report is for a 4.5mm va-locking compression plate (lcp) curved condylar plate.This is report 1 of 1 for (b)(4).
 
Event Description
This report is for one (1) 4.5mm va-lcp curved condylar plate/12 hole/266mm/left.
 
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.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.Device history lot , part: 02.124.413, lot: 9762416, manufacturing site: mezzovico, release to warehouse date: 16.Dec.2015.The device history record shows this lot of(b)(4) pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Device history batch null, device history review review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.Investigation summary background: it was reported that on an unknown date, the twelve (12) hole left variable angle (va) condylar plate would not thread into an aiming arm.There was a surgical delay of ten (10) minutes.Procedure was successfully completed with the use of a ten (10) hole left va condylar plate.Patient outcome was good.Device evaluation: investigation flow: device interaction/functional and damage: visual (appearance not as expected).Visual inspection: the returned 4.5mm va-lcp curved condylar plate was examined and found to be without visually identifiable defect or deficiency which may have contributed to the reported complaint condition.The aiming arm does not connect directly to the plate, but rather it connects to the insertion handle (03.231.001) which is secured to the plate using an interlocking bolt.The interlocking bolt for 4.5mm va-lcp condylar insertion handle (03.231.005) threads into the locking portion of the first combi hole.The associated threads on the plate were examined and found absent any deformation.As no defects were identified the complaint is unconfirmed.Functional test: the interlocking bolt, insertion handle and aiming arm were not returned for evaluation, as such it is not possible to functionally test the returned plate.Conclusion the complaint condition was unable to be visually confirmed as no damage was noted to the mating threads of the plate; additionally as the interlocking bolt, insertion handle and aiming arm were not returned the complaint condition was unable to be replicated functionally.As no defects or deficiencies were identified the complaint is unconfirmed.The system risk document was found to adequately address the reported complaint condition (see action).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
4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/LEFT
Type of Device
IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key8265041
MDR Text Key133707612
Report Number2939274-2019-55986
Device Sequence Number1
Product Code JDP
UDI-Device Identifier10886982042880
UDI-Public(01)10886982042880
Combination Product (y/n)N
PMA/PMN Number
K110354
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number02.124.413S
Device Catalogue Number02.124.413
Device Lot Number9762416
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2019
Date Manufacturer Received02/22/2019
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age85 YR
Patient Weight41
-
-