MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.003.461S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Code Available (3191); Malunion of Bone (4529)
Date of Event	03/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 or Problem Description
It was reported on (b)(6) 2019, the surgeon called and asked which side (left or right) was an expert lateral femoral nail implanted and was informed that it was implanted on the right femur.Originally, the patient had an open reduction internal fixation (orif) surgery for intramedullary nailing of the right femur due midshaft femur fracture using a left lateral entry nail last (b)(6) 2019.However, the nail that was used was for the left.Thus, a planning for removal of the nail was successfully done and was replaced with right left on (b)(6) 2019.There was no known defect with the implant.Patient status is unknown.Concomitant device/s reported: unknown screws (part# unknown, lot# unknown, quantity unknown) and unknown end caps (part# unknown, lot# unknown, quantity unknown).This report is for one (1) 11mm ti lateral entry femoral recon nail-ex/400mm/lt-sterile.This is report 1 of 1 for (b)(4).
Event or Problem Description
On (b)(6) 2019: updated event description: it was reported that fractured segments started to grow callus, and osteotomes were used to break callus, shift or mobilize the segments, reduce the osteotomy, and restore the natural femoral bow of the femur.The procedure was successfully completed.There was no surgical delay.
Additional 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.Event (b)(6) 2019: updated event description: concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.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.
Additional 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: h6: codes updated to imdrf.H6 - health effect - clinical code: e20.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.
Additional 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.Photo investigation: the device was not returned.A photo-investigation was performed on the images in "pc-000495847 005_rocco 3 femur views" located in pc under notes & attachments section.Upon inspecting all the x-rays provided under notes & attachments section, the bow of the femoral nail was observed to be in the opposite direction than it is intended, hence confirming the allegation.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection was not completed.As part of document/specification review we have reviewed 04_003_441 rev j (current and manufactured) and no design issues or discrepancies were identified.Conclusion the complaint condition can be confirmed during photo/video investigation.During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot - part #: 04.003.461s; synthes lot #: 7322448; release to warehouse date: 04 dec 2013; manufactured by: selzach; supplier: (b)(4).No ncr's generated during production.Device history review - review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
Additional 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, h6: 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.
Event or Problem Description
Updated 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.He also reports r knee pain that was not present prior to femur fracture in march.He reports that he has had a mri of knee that 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 additional updates made on this complaint: added screws as ip since it was mention of subsequent encounter closed fracture with malunion.Products found in implant record (b)(4).Also added lot number for the reported nail.Added medical history and relevant test/lab data.Corrected patient's gender and initials.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H10 additional narrative: b5: updated event description.B6: updated tests/lab data.B7: medical history.D 4, d6a, d6b: updated.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.

• Brand Name: 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/LT-STERILE
• Common Device Name: 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 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8837021
• Report Number: 2939274-2019-59425
• Device Sequence Number: 2742567
• Product Code: HSB
• UDI-Device Identifier: 10886982082282
• UDI-Public: (01)10886982082282
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/21/2019
• Device Model Number: 04.003.461S
• Device Catalogue Number: 04.003.461S
• Device Lot Number: 6552400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 08/09/2019; 07/09/2021; 10/04/2021; 10/28/2021; 01/18/2022; 01/18/2022
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/26/2019; 08/03/2021; 10/06/2021; 10/28/2021; 02/14/2022; 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - END CAPS; UNK - SCREWS: TRAUMA; UNK - END CAPS; UNK - SCREWS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male