MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD; ROD,FIXATION,INTRAMEDULLARY

Model Number	04.013.000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Nonunion/Delayed-union Bone Fracture (2369)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.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 on (b)(6) 2018, the patient underwent hardware removal of retrograde-antergrade femoral nail (rafn), two (2) locking screws, a spiral blade, a titanium end cap, and a distal femur replacement.The hardware removal was due to infection and non-union.The patient underwent an open reduction internal fixation (orif) of the distal femur on an unknown date in (b)(6) 2013 due to a fracture.The patient had a revision with an intramedullary (im) nail on an unknown date in (b)(6) 2014.On an unknown date in (b)(6) 2016, the patient had the intramedullary (im) nail removed and irrigation & debridement (i&d) performed where an antibiotic spacer and ex-fix system were placed due to infection and nonunion.The hardware used on these previous cases were unknown.The ex-fix was removed on an unknown date in (b)(6) 2017 and the rafn nail was implanted.Patient consulted surgeon and had imaging performed on (b)(6) 2018.During the hardware removal, additional medical intervention done was placement of antibiotic spacer and resection of the distal femur.All the above mentioned hardware was removed intact.The procedure was completed successfully.There was no surgical delay.Patient outcome was good.This report is for one (1) end cap this is report 3 of 4 for (b)(4).

• Brand Name: TI END CAP T40 STRDRV 0MM EXT RETRO FEMORAL NAIL-EX SPRL BLD
• 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: 7774675
• Report Number: 2939274-2018-53282
• Device Sequence Number: 19085644
• Product Code: HSB
• UDI-Device Identifier: 10886982087348
• UDI-Public: (01)10886982087348
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K033618
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2018

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?: No
• Operator of Device: Health Professional
• Device Model Number: 04.013.000
• Device Catalogue Number: 04.013.000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2018
• Initial Report FDA Received Date: 08/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 88