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	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
It is unknown when the event occurred.This report is for 1 (one) lateral entry femoral recon nail/unknown lot.Complainant part is not expected to be returned for manufacturer review/investigation.Device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 patient underwent a revision of a 11 mm lateral entry femoral recon nail and at least two (2) recon screws (5.0 mm locking screws) on (b)(6) 2017 due to nonunion.All devices were removed intact, and the patient was then revised to another recon nail.There were no complications during the revision of the implants and no additional interventions were required to complete the surgery successfully.The patient is reported to be in stable condition.This complaint involves at least three (3) devices.Concomitant devices reported: unknown screws (part # unknown, lot # unknown, quantity # unknown).This report is for the nail.This report is 1 of 2 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.
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.

• 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; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7146027
• Report Number: 2939274-2017-50418
• Device Sequence Number: 16378713
• Product Code: HSB
• UDI-Device Identifier: 10886982082275
• UDI-Public: (01)10886982082275(10)LOTUNKNOWN
• 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,Followup,Followup
• Report Date (Section B): 11/28/2017

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 Model Number: 04.003.460S
• Device Catalogue Number: 04.003.460S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Supplement Date Received by Manufacturer: 11/28/2017; 01/23/2018
• Initial Report FDA Received Date: 12/26/2017
• Supplement Report FDA Received Date: 01/19/2018; 01/24/2018
• 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