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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 65MM; APPLIANCE,FIXATION,NAIL
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 65MM; APPLIANCE,FIXATION,NAIL Back to Search Results
Catalog Number 212.222
Device Problems Migration or Expulsion of Device (1395); Migration (4003)
Patient Problems Failure of Implant (1924); Not Applicable (3189); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
510k: this report is for an unknown device/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 the patient underwent a revision surgery on (b)(6) 2018, due to a loss of distal fixation.The patient initially had an open reduction internal fixation left femur surgery on (b)(6) 2018.A variable angle locking compression plate (lcp) condylar plate was implanted with four (4) locking screws distally and four (4) cortical screws proximally.It was reported that the distal locking screws backed out.The surgeon removed the va lcp plate and converted to an external fixator.It is unknown if there was a surgical delay.Patient outcome was not specified.Concomitant device reported: variable angle locking compression plate (lcp) condylar plate (part number 02.124.417, lot number l832872, quantity of 1) , unknown cortical screws (part number unknown, lot number unknown, quantity of 4).This is report 1 of 1 for (b)(6).
 
Event Description
Concomitant device reported: 4.5mm ti cortex self-tapping 32mm (part number 414.832, lot unknown, quantity 1); 4.5mm ti cortex self-tapping 38mm (part number 414.838, lot unknown, quantity 2); 4.5mm ti cortex self-tapping85mm (part number 414.885, lot unknown, quantity 1); and 4.5mm ti cortex screw 85mm (part number 414.085, lot unknown, quantity 1).This report is for one (1) 5.0mm locking screw slf-tpng with t25 stardrive recess 65mm this is report 1 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.Additional product codes hrs, hwc.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A review of the device history records has been requested.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.H10 additional narrative: h3, h6: the implant was received with the reported condition of ¿functional migration/backout/pull-out: rm/si.¿ please note no x-rays were provided.Flow: device interaction/functional visual inspection: the 5 mm locking screw (part: 212.222, lot: unknown) was received at us cq with the threads on the screw head and screw shaft stripped.These are indications that the screws were implanted and then explanted.Functional test: a functional test could not be performed as the conditions leading to backout could not be recreated at cq.The received condition does not agree with the complaint description and the complaint condition could not be replicated due to reasons stated above.Dimensional inspection: dimensional analysis was completed, the outer diameter of the screw head measured 6.72 mm.This is within specification of 6.78 mm ± 0.2.The shaft diameter measured 4.99 mm which is within specification of 4.90 to 5.05 mm.Document/specification review: the following drawing(s) was reviewed; locking screw 5*xx st sd.A dhr review could not be performed as the lot number is unknown.The risk management review was completed.Conclusion: the complaint condition is not confirmed as there is no x-ray showing the migration/backout/pullout of the locking screw and the complaint condition cannot be replicated.Based on the available information, it is not possible to determine a definitive root cause for the complaint condition.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.H6: code 3191 used to capture required surgical intervention and device removal.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.
 
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Brand Name
5.0MM LOCKING SCREW SLF-TPNG WITH T25 STARDRIVE RECESS 65MM
Type of Device
APPLIANCE,FIXATION,NAIL
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
MDR Report Key7850748
MDR Text Key119372864
Report Number2939274-2018-53625
Device Sequence Number1
Product Code KTT
Combination Product (y/n)N
PMA/PMN Number
K000682
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 09/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number212.222
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2018
Initial Date Manufacturer Received 08/20/2018
Initial Date FDA Received09/06/2018
Supplement Dates Manufacturer Received09/20/2018
10/12/2018
Supplement Dates FDA Received10/05/2018
10/12/2018
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight54
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