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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 70MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY
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WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 70MM FOR IM NAILS; ROD,FIXATION,INTRAMEDULLARY Back to Search Results
Catalog Number 04.005.560
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Malunion of Bone (4529)
Event Date 03/03/2019
Event Type  Injury  
Manufacturer Narrative
Product complaint # (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/ investigation.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
On (b)(6) 2019, patient had fractured r femur with intermedullary nailing but continued to have difficulty with r le as well as increasing knee pain.And went in for a second opinion and found that the surgery had l intermedullary nail instead of a r intermedullary nail.As per doctor reports that the intermedullary nail was position incorrectly.This made the natural curve of the femur incorrect.Also, reported that r knee pain that was not present prior to femur fracture in (b)(6).The mri of knee was negative.On (b)(6) 2019, patient had revised due to comminuted fracture of shaft of right femur, subsequent encounter closed fracture with malunion.This complaint involves five (5) number of devices.This report is for (1) 5.0mm ti locking screw w/t25 stardrive 70mm for im nails.This report is 4 of 5 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.H10 additional narrative: b5, d6.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
Patient was implanted with a left femoral rod into right leg.It was required that the rod be flipped, giving it a posterior bow in order to correct the error.The patient underwent corrective surgery on (b)(6) 2019.
 
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.A product investigation was competed: upon visual inspection, no issues were observed with the device apart from explanation marks from the nail removal procedure.Upon inspecting all the x-rays and images provided, the bow of the femoral nail was observed to be in the opposite direction than it is intended, hence confirming the allegation.The current and manufactured revision of drawings were reviewed; no design issues or discrepancies were noticed.This complaint is confirmed for the returned device, however, there was no issue with the design or manufacturing of the device.A wrong sided implant was selected by the surgeon while performing the surgery.The etching on the distal end of the device clearly states that a left nail was used during the surgery.There was no indication that a design or manufacturing issue contributed to the complaint condition.Based on the investigation findings, it has been determined that no new corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 TI LOCKING SCREW W/T25 STARDRIVE 70MM FOR IM NAILS
Type of Device
ROD,FIXATION,INTRAMEDULLARY
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key12583527
MDR Text Key274956676
Report Number2939274-2021-05930
Device Sequence Number1
Product Code HSB
UDI-Device Identifier07611819760394
UDI-Public(01)07611819760394
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172157
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number04.005.560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age42 YR
Patient SexMale
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