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

Model Number	04.003.460S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Impaired Healing (2378)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.It is unknown when non-union occurred and device failure occurred.Event description updated.Implant date: unknown date in (b)(6) 2017.It is unknown if devices were explanted and if they were explanted dates are unknown.Device is not expected to return for investigation.Pma #: provided.Device history record review, manufacturing location: (b)(4), manufacturing date: 29-sep-2016, expiration date: 31-aug-2025.Part #: 04.003.460s, lot#: h196945 (sterile) ¿ 11 mm ti lateral entry femoral recon nail-ex/400 mm/rt - sterile.Quantity 6.Inspection sheet met inspection acceptance criteria.Component parts reviewed: part 21014, lot: 7922124 meet specifications.Raw material for titanium was received from dynamet incorporated.Product certification was received from dynamet and raw material receiving/putaway checklist meet specification.(b)(4) was initiated at operation 190 for boxing on (b)(6) 2016.This is a planned non conformance for "(b)(4) rev.1 does not require to repeat steps 3.08 and 3.09 for each part." (b)(4) was initiated at operation 20 for gundrill and 40 bend radius on (b)(6) 2016 for "implementing the jbs for gun drill in the nail department, six pack holders are called out on (b)(4) these are still awaiting production due to machine times." issue is not relevant to the complaint condition.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.(b)(4), ethicon (abq), ¿sterility documentation was reviewed and determined to be conforming.¿6: device history record review the investigation could not be completed; no conclusion could be drawn, as no product was received.(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
Event or Problem Description
(b)(4) it was reported a patient originally fell on or around (b)(6) 2017 and was treated surgically for an initial right intertrochanteric femur fracture with an 11 mm lateral femoral nail.The exact implant date is unknown.Subsequently, the patient fell a second time on an unknown date in (b)(6) 2017.It was determined the femoral nail broke and the patient presented with a non-union.It is possible the secondary fall led to the device failure.It is unknown if a revision surgery occurred and devices were explanted.Patient status is unknown.This is report 1 of 1 for (b)(4).

• Brand Name: 11MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC
• MDR Report Key: 7322620
• Report Number: 2939274-2018-50919
• Device Sequence Number: 1605885
• Product Code: HSB
• UDI-Device Identifier: 10886982082275
• UDI-Public: (01)10886982082275(17)250831(10)H196945
• Combination Product (Y/N): N
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/06/2018

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: 08/31/2025
• Device Model Number: 04.003.460S
• Device Catalogue Number: 04003460S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/06/2018
• Initial Report FDA Received Date: 03/07/2018
• 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