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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC CORTSCR Ø4.5 SELF-TAP L36 TI; SCREW,FIXATION,BONE
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC CORTSCR Ø4.5 SELF-TAP L36 TI; SCREW,FIXATION,BONE Back to Search Results
Catalog Number 414.836
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
This report is for an unk - screws: cortex trauma/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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
Device report from synthes reports an event in (b)(6) as follows: it was reported on an unknown date that the patient has distal femur fracture on (b)(6) 2019 and the patient was underwent for the implant removal index surgery on (b)(6) 2019 - orif- distal femur lcp- started on non-weight bearing ambulation with support.The facility name of original implant is titanium lcp distal femur plate 11-hole left side.All implants are successfully explanted without any issue.There was no reported surgery delay.The patient was in pain.This is report 3 of 4 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.D4: updated.G1: updated.H3, h6: investigation summary: investigation site: cq zuchwil.Selected flow(s): damaged: visual | examples: deformed/bent/cracked/broken.Visual inspection: upon visual inspection of the complaint device it can be seen that the screw is broken at the neck section (between head and shank), this thus confirming the complaint description.In addition, the screw shank has sings (damage) most likely from pliers.Dimensional inspection: the investigation has shown that the cause of complained malfunction is a post-manufacturing caused use related damage at the device, therefore no dimensional inspection is needed.Furthermore, the complaint relevant dimensions cannot be checked for dimensional accuracy, because of the damage.Document/specification review: drawings and revisions are in accordance to dhr of production lot 9021916.All relevant features are defined on the used drawing revisions of dhr of production lot 9021916.Summary: as per selected investigation flow, the investigations performed didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.There is no particularize information what's happened to this article by customer, unfortunately we are not able to determine the exact reason for this occurrence, but we assume that an overloading situation could have led to this issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part: 414.836.Lot: 9021916.Manufacturing site: hägendorf.Release to warehouse date: jun 12, 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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.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.
 
Event Description
Concomitant devices reported: locking compression plate 4.5/5 le 11hole l276 tan (part# 422.257, lot#1l39261, quantity 1), locking screw self-tap l46 tan (part#413.346, lot#l111268, quantity 1), locking screw self-tap l50 tan (part:#413.350, lot#l939979, quantity 1), locking screw self-tap l55 tan (part#413.355, lot#l619359, quantity 1), locking screw self-tap l65 tan (part#413.365, lot#l098768, quantity 1), locking screw self-tap l70 tan (part#413.370, lot#l133196, lot#l123910, quantity 2), cortex screw self-tap l34 ti (part#414.834, lot#l203703, quantity 1), cortex screw self-tap l36 ti (part#414.836, lot#l131395, quantity 1), cortex screw self-tap l40 ti (part#414.840,lot#2648743, quantity 1).
 
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Brand Name
CORTSCR Ø4.5 SELF-TAP L36 TI
Type of Device
SCREW,FIXATION,BONE
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key9535706
MDR Text Key185756806
Report Number2939274-2019-62808
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 12/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number414.836
Device Lot Number9021916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/12/2020
Date Manufacturer Received02/04/2020
Patient Sequence Number1
Treatment
CORTSCR Ø4.5 SELF-TAP L34 TI; CORTSCR Ø4.5 SELF-TAP L34 TI; CORTSCR Ø4.5 SELF-TAP L36 TI; CORTSCR Ø4.5 SELF-TAP L36 TI; CORTSCR Ø4.5 SELF-TAP L40 TI; CORTSCR Ø4.5 SELF-TAP L40 TI; LCP-DF 4.5/5 LE 11HO L276 TAN; LCP-DF 4.5/5 LE 11HO L276 TAN; LCP-DF 4.5/5 LE 11HO L276 TAN; LOCKSCR Ø5 SELF-TAP L46 TAN; LOCKSCR Ø5 SELF-TAP L46 TAN; LOCKSCR Ø5 SELF-TAP L50 TAN; LOCKSCR Ø5 SELF-TAP L50 TAN; LOCKSCR Ø5 SELF-TAP L55 TAN; LOCKSCR Ø5 SELF-TAP L55 TAN; LOCKSCR Ø5 SELF-TAP L65 TAN; LOCKSCR Ø5 SELF-TAP L65 TAN; LOCKSCR Ø5 SELF-TAP L70 TAN; LOCKSCR Ø5 SELF-TAP L70 TAN; UNK - SCREWS: TRAUMA
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight60
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