MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/380MM/RT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.456S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.Patient identifiers and age not available for reporting date of event: it is unknown when non-union began.Device is not expected to return.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 that on (b)(6) 2018, a patient underwent revision of a lateral entry femoral nail construct due to one (1) broken lateral entry femoral nail, and complete nonunion.The initial construct included one (1) lateral entry femoral nail (broken), one (1) intact distal interlocking screw and two (2) intact proximal recon screws, which were implanted on (b)(6) 2018 while the patient underwent a revision of a tfna construct due to a broken nail.The surgeon believes that the complete nonunion was due to delayed healing caused because of the immunosuppressants that the patient takes for their rheumatoid arthritis, which the surgeon describes as a total biological train-wreck for the healing of fractures.Cultures were taken during the surgery to check for infection as a general procedure, although no infection was suspected.The results for the cultures are unknown.Multiple lateral and ap images were taken during the procedure.The surgery was reported to have been completed successfully without any additional interventions or complications reported.The patient was reported in a stable condition.Concomitant devices reported: unknown proximal recon screws (part# unknown, lot# unknown, quantity# 2).Unknown distal interlocking screws (part# unknown, lot# unknown, quantity# 1).This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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
Correction to event description; implant date is (b)(6), 2017 instead of (b)(6), 2018.
Additional Manufacturer Narrative
A device history record (dhr) review was performed for manufacturing location: monument, manufacturing date: 07-jun-2017, expiration date: 30-apr-2026, part #: 04.003.456s, lot#: h377897 (sterile) ¿ 11mm ti lateral entry femoral recon nail-ex/380mm/rt - sterile.Quantity 4.Inspection sheet for inspect dimensional 4003id440 rev: l met inspection acceptance criteria.Component parts reviewed: part 21014, lot: h041200 meet specifications.Raw material received from perryman company.Certified test report received from perryman company for titanium ingot meet specification.Raw material receiving/putaway checklist meets requirement.Scn no: 13801, ethicon (abq), ¿sterility documentation was reviewed and determined to be conforming.¿: no non-conformance reports (ncrs) were generated during production.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.

• Brand Name: 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/380MM/RT-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7421451
• Report Number: 2939274-2018-51580
• Device Sequence Number: 11036294
• Product Code: HSB
• UDI-Device Identifier: 10886982082251
• UDI-Public: (01)10886982082251(17)260430(10)H377897
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/15/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: 04.003.456S
• Device Catalogue Number: 04.003.456S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018; 04/30/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 04/11/2018; 05/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 81