MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC 11MM/130 DEG TI CANN TFNA 235MM/LEFT - STERILE; ROD, FIXATION, INTRAMEDULLARY

Model Number	04.037.145S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient¿s weight is not available for reporting.Date of event: date of postoperative nail breakage is unknown.Implanted date: device was implanted approximately one year prior to revision surgery.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 a patient had an intermediate length tfn-advanced proximal femoral nailing system (tfna) implanted approximately one year ago at an outside hospital.Patient was admitted to the hospital following a fall.The implanted tfna broke in the area where the helical blade passes through the nail.The helical blade was remained in appropriate position.It was suspected that the patient sustained a femoral neck fracture in the fall.Revision surgery was performed on (b)(6) 2018, where the surgeon removed a single intact locking screw, an intact helical blade, and the broken nail (two pieces).The patient had a modular distal fixation stem from another company implanted and a bi-polar head.The surgery was completed successfully with no surgical delay.Patient status was reported as stable.X-rays were taken but not available.Concomitant devices reported: locking screw (part# unknown, lot# unknown, quantity 1), helical blade (part# unknown, lot# unknown, quantity 1).This report is for one (1) 11mm/130 deg ti cann tfna 235mm/left - sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 11MM/130 DEG TI CANN TFNA 235MM/LEFT - 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: 7222048
• Report Number: 2939274-2018-50414
• Device Sequence Number: 1343322
• Product Code: HSB
• UDI-Device Identifier: 10886982096579
• UDI-Public: (01)10886982096579(17)EXPIRATIONDATEUNKNOWN(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• 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): 01/06/2018

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 Model Number: 04.037.145S
• Device Catalogue Number: 04.037.145S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2018
• Initial Report FDA Received Date: 01/26/2018
• 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: 79 YR