MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER; ROD,FIXATION,INTRAMEDULLARY

Model Number	456.419S
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 date of birth, gender and weight not available for reporting.Date of event: unknown.Original implant date is unknown/ device is not expected to return/ reporter telephone number not available.Part #: 456.419s, lot#: 7823165 (sterile) - 11 mm/130 deg ti cann troch fixation nail 380 mm/left - sterile.Quantity 6.Manufacturing location: (b)(4), manufacturing date: 21-oct-2014 , expiration date: 30-sep-2023.Component parts reviewed: 456.314.3 - trochanteric fixation nail lock driver tfn, bp 55, lot 7748583.The 456.315.2 - trochanteric fixation nail lock 130 deg lock prong tfn, bp 58, lot 7797398.The 21069 - raw material lot bp-80 lot - 7708358 for titanium received from supplier (b)(4).Ati allvac certificate of test meets specification.Raw material receiving/putaway checklist meet requirements.Inspection sheet for inspect dimensional 456id410 rev: v, final inspection 456fi410 rev: j meet inspection acceptance criteria.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.Scn no: 10664, ¿sterility documentation was reviewed and determined to be conforming.¿ 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 the patient underwent a revision procedure on (b)(6) 2018 due to a broken titanium trochanteric fixation nail (tfn) and unhealed fracture.The nail broke at the junction of the helical blade.Patient has comorbidities of metastatic cancer and chronic nicotine dependence; therefore, the fracture never healed causing the tfn to fail and break two (2) years later.The nail, helical blade and distal locking screw were removed intact and a new tfn nail was implanted.No surgical delay or patient harm.Procedure was completed successfully.Patient outcome is stable.Concomitant devices reported: helical blade (part # unknown, lot # unknown, quantity # 1).Distal locking screw (part # unknown, lot # unknown, quantity # 1).This is report 1 of 1 for (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TROCH FIXATION NAIL 380MM/LEFT-STER
• 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: 7260237
• Report Number: 2939274-2018-50575
• Device Sequence Number: 997720
• Product Code: HSB
• UDI-Device Identifier: 10886982227850
• UDI-Public: (01)10886982227850(17)230930(10)7823165
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K011857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2018

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: 09/30/2023
• Device Model Number: 456.419S
• Device Catalogue Number: 456.419S
• Device Lot Number: 7823165
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/09/2018
• 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: 50 YR