MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 15MM TI LATERAL ENTRY FEMORAL RECON NAIL-EX/400MM/RT-STERILE; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.003.860S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional narrative: (b)(4).Date of non-union is not known.Date of implant reported as approximately one year prior to removal.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.Dhr review: (b)(4), manufacturing date: 01-may-2014, expiration date: 31-mar-2023.Part #: 04.003.860s, lot#: 7671625 (sterile) ¿ 15mm ti-lateral entry femoral recon nail-ex/400mm/rt - sterile.Quantity 6.Inspection sheet for inspection dimensional & final inspection met inspection acceptance criteria.Component parts reviewed: part 21069, lot: 7506606 for titanium received from (b)(4).(b)(4) certificate of test for titanium meets specification.Raw material receiving/putaway checklist meet specification.No ncrs were generated during production.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.¿sterility documentation was reviewed and determined to be conforming.¿ 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 that a hardware removal was performed due to atrophic non-union of a right femur on (b)(6) 2017.The original procedure was performed on an unknown date; it is believed to be about a year ago.Removed hardware included: one nail and two recon screws -all intact.The removal was completed without incident.The patient was revised to a large fragment plate and screws.Bone aspirate autograft was used for the non-union.It is noted that the patient is on fosamax.The procedure was completed successfully with the patient in stable condition.This report is for one (1) 15mm lateral entry femoral recon nail-ex.(b)(4).

• Brand Name: 15MM 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; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7189166
• Report Number: 2939274-2018-50252
• Device Sequence Number: 11017262
• Product Code: HSB
• UDI-Device Identifier: 10886982083074
• UDI-Public: (01)10886982083074(17)230331(10)7671625
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K040336
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 04.003.860S
• Device Catalogue Number: 04.003.860S
• Device Lot Number: 7671625
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/15/2018
• 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 Age: 49 YR
• Patient Weight: 92