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U.S. Department of Health and Human Services

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

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC ROD, FIXATION, INTRAMEDULLARY Back to Search Results
Device Problem Unintended Movement (3026)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Patient¿s information is not available. Date of event: unknown. This report is for an unknown synthes helical blade /unknown lot. Part and lot number are unknown; udi number is unknown. Implanted, explanted: 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) chapman 2018. Pdf].
 
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, west chester, pa) 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: a (b)(6)-year-old female patient with a bmi of (b)(6) 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. A (b)(6)-year-old female with a bmi of (b)(6) 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. A (b)(6)-year-old male with a bmi of (b)(6) 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. A (b)(6)-year-old female with a bmi of (b)(6) 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. A (b)(6)-year-old female with a bmi of (b)(6) 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 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. A (b)(6)-year-old female with a bmi of (b)(6) 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 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. A (b)(6)-year-old female with a bmi of (b)(6) 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)-year-old female patient who had the helical blade perforated the bone medially. This report is for an unknown synthes helical blade. This is report 5 of 7 for complaint (b)(4).
 
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Type of DeviceROD, 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 Key7560422
MDR Text Key109886687
Report Number2939274-2018-52370
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received06/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/10/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 06/01/2018 Patient Sequence Number: 1
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