MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC; ROD, FIXATION, INTRAMEDULLARY

Device Problem Unintended Movement (3026)

Patient Problems Failure of Implant (1924); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown synthes helical blade /unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(510k): unknown, as specific part and lot numbers for helical blade is not provided.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: chapman, t.Et al (2016), helical blade versus screw fixation in the treatment of hip fractures with cephalomedullary devices: incidence of failure and atypical 'medial cutout', journal of orthopaedic trauma, pages 1-19 (united states of america) the goal of this retrospective study is to help identify the true incidence of failure of these devices (helical blade fixation) in the low energy hip fracture population, to determine whether blades are advantageous or disadvantageous in this cohort, and examine modes of failure an attempt to gain a better understanding of predictors of failure.Between september 2010 and january 2016, 126 patients (104 female, 22 male) with an average age of 83.7 years (range 50-100) were treated either a long or short trochanteric fixation nail (tfn; depuy synthes, (b)(4)) with a helical blade or lag screw fixation into the femoral head for cephalomedullary fixation of hip fractures.The first 71 consecutive patients were being treated with a helical blade and the final 55 patients treated with a screw.For all patients, the cannulated reamer and distal locking screws were always used.Average follow-up was 3.6 months (20-558 days).28 patients never made a follow up appointment.The tip apex distance (tad) was measured for all cases on radiographs taken on post-operative day one.Failures were defined as non-union or failure of fixation.Failure of fixation was defined as superolateral cutout or medial cutout.The following complications were reported: (b)(6) female patient with a bmi of 17.7 was treated with a trochanteric fixation nail (tfn) short with helical blade for proximal locking.Time to failure post-operatively was at 2.1 weeks with a tip apex distance (tad) score of 12.5mm.Type of failure was medial and upon review of the radiographs, the sliding mechanism of the device did not appear to telescope.Rather the femoral head translated laterally along the axis of blade causing a medial perforation of the helical blade.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement.Reduction quality was reported as good.(b)(6) female with a bmi of 20.0 was treated with a trochanteric fixation nail (tfn) short with helical blade for proximal locking.Time to failure post-operatively was 28.0 week with a tip apex distance (tad) score of 24mm.Type of failure was medial and upon review of radiographs, the sliding mechanism of the device did not appear to telescope.Rather the femoral head translated laterally along the axis of blade causing a medial perforation of the helical blade.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement.Reduction quality was reported as poor, which could have resulted from various degrees of rotational malalignment or fracture distraction.(b)(6) male with a bmi of 22.8 was treated with a trochanteric fixation nail (tfn) long with helical blade for proximal locking.Time to failure post-operatively was at 5.4 weeks with a with tip apex distance (tad) score of 20.3mm.Type of failure was superior.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement reduction quality was reported as acceptable, which could have resulted from various degrees of rotational malalignment or fracture distraction.(b)(6) female with a bmi of 25.9 0 was treated with a trochanteric fixation nail (tfn) short with helical blade for proximal locking.Time to failure post-operatively was at 7.3 weeks with a tip apex distance (tad) score of 21mm.Type of failure was medial and upon review of radiographs, the sliding mechanism of the device did not appear to telescope.Rather the femoral head translated laterally along the axis of blade causing a medial perforation of the helical blade.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement.Reduction quality was reported as ¿acceptable¿ which could have resulted from various degrees of rotational malalignment or fracture distraction.(b)(6) female with a bmi of 30.3 was treated with a trochanteric fixation nail (tfn) short with helical blade for proximal locking.Time to failure post-operatively was at 4.7 weeks with with a tip apex distance (tad) score of 17.2mm.Type of failure was medial and upon review of radiographs, the sliding mechanism of the device did not appear to telescope.Rather the femoral head translated laterally along the axis of blade causing a medial perforation of the helical blade.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement.Reduction quality was reported as good.(b)(6) female with a bmi of 31.2 was treated with a trochanteric fixation nail (tfn) short with helical blade for proximal locking.Time to failure post-operatively was at 48.7 weeks with with a tip apex distance (tad) score of 18mm.Type of failure was superior.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement.Reduction quality was reported as good.(b)(6) female with a bmi of 20.1 was treated with a trochanteric fixation nail (tfn) short with helical blade for proximal locking.Time to failure post-operatively at 3.0 weeks with a tip apex distance (tad) score of 15mm.Type of failure was media and upon review of radiographs, the sliding mechanism of the device did not appear to telescope.Rather the femoral head translated laterally along the axis of blade causing a medial perforation of the helical blade.It is unknown if this patient was treated with exchange of the helical blade to a screw and protected weight bearing until fracture union or underwent conversion to total hip replacement.Reduction quality was reported as good.This report is for (b)(6) female patient who had the helical blade perforated the bone medially.This report is for an unknown synthes helical blade.This is report 2 of 7 for complaint (b)(4).A copy of the literature article is being submitted with this medwatch.

• Type of Device: ROD, FIXATION, INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7560386
• MDR Text Key: 109896932
• Report Number: 2939274-2018-52367
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR