MAUDE Adverse Event Report: ACUMED, LLC; SCREW, FIXATION, BONE

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Report 14 of 51.In the article " compressive buttress compared with of-axial screw fxation for vertical femoral neck fractures in young adults: a prospective, randomized controlled trial" by yin, b, et al, the authors wanted to compare the clinical outcomes of compressive buttress screw (cbs) fixation, which per the authors is a novel screw fixation strategy, to of-axial screw fixation (off-axial partial threaded cannulated screw, optcs) for vertical femoral neck fractures (fnfs) in young adults.This study was a prospective, randomized controlled trial at the author's center.From january 2016 to july 2017, all adult patients younger than 55 years presenting to their level-i trauma center with fnfs were considered eligible for enrollment.In this study a total of 146 adults younger than 55 years old with high-energy pauwels type iii fnfs were randomized to receive cbs fixation or optcs fixation.Per the authors, all operative procedures were performed by orthopedic traumatologists (h.S.And w.Z.), with more than 10 years of experience within forty-eight hours after presentation.All patients received a single dose of antibiotics at the induction of general anesthesia.In optcs fixation, four guide wires were inserted.One was placed centrally, inserted from the lateral aspect of the greater trochanter and close to the proximal cortex of the femoral neck, toward the central and lower part of the femoral head at an angle perpendicular to the vertical fracture line.The other three guide wires were inserted in parallel along the femoral neck axis in a triangular configuration.The proximal guide wire of the triangle was placed posterior to the off-axis wire in order to increase posterior stability.Following this, the transverse off-axis ptcs with washer was implanted to compress the fracture site and eliminate the fracture gap.This was followed by regular triangular implantation with the same screw type (different manufacturer).In cbs cohort, one ptcs screw with washer was placed in proximal-central position as the first screw in order to compress the fracture line statically.Following this, two fthcs screws (acutrak 6/7, acumed, hillsboro, or, usa) were implanted parallelly the proximal ptcs in the distal position proximal to the level of lesser trochanter.The anteroposterior distance of the parallel screws was increased as much as possible on the lateral view to obtain greater stability.In both groups, screw length was determined by intraoperative measurement.Primary outcomes were complication rates, including fixation failure, fracture nonunion, and avascular necrosis of the femoral head (anfh) at 24 months after treatment.Fixation loosening, femoral neck shortening and varus collapse, patient function and quality of life using the harris hip score (hhs), and euro qol-5 dimensional-5 levels (eq-5d-5l) questionnaire (including eq-5d-5l and eq-vas) were assessed as secondary outcomes at 24 months.This is an off-label indication, acumed labeling only states the use of these screws in femoral condyle fractures.The following complications were reported in the article: 6 instances of fixation failure, 1 nonunion, 4 avascular necrosis of the femoral head (anfh), 11 fixation loosening, 11 lateral withdrawal, 1 medial migration, 17 shortening and varus collapse moderate to severe.

Manufacturer Narrative

Manufacturing and inspection records could not be reviewed as device model number and batch/lot number is unknown.The device was not returned for evaluation.Based on the information received, the root cause could not be determined.Related reports: 3025141-2024-00079, 3025141-2024-00080, 3025141-2024-00081, 3025141-2024-00082, 3025141-2024-00083, 3025141-2024-00084, 3025141-2024-00085, 3025141-2024-00086, 3025141-2024-00087, 3025141-2024-00088, 3025141-2024-00089, 3025141-2024-00090, 3025141-2024-00091, 3025141-2024-00093, 3025141-2024-00094, 3025141-2024-00095, 3025141-2024-00096, 3025141-2024-00097, 3025141-2024-00098, 3025141-2024-00099, 3025141-2024-00100, 3025141-2024-00101, 3025141-2024-00102, 3025141-2024-00103, 3025141-2024-00104, 3025141-2024-00105, 3025141-2024-00106, 3025141-2024-00107, 3025141-2024-00108, 3025141-2024-00109, 3025141-2024-00110, 3025141-2024-00111, 3025141-2024-00112, 3025141-2024-00113, 3025141-2024-00114, 3025141-2024-00115, 3025141-2024-00116, 3025141-2024-00117, 3025141-2024-00118, 3025141-2024-00119, 3025141-2024-00120, 3025141-2024-00121, 3025141-2024-00122, 3025141-2024-00123, 3025141-2024-00124, 3025141-2024-00125, 3025141-2024-00126, 3025141-2024-00127, 3025141-2024-00128, and 3025141-2024-00129.

• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): ACUMED, LLC; 5885 ne cornelius pass road; hillsboro OR
• Manufacturer (Section G): ACUMED LLC; 5885 ne cornelius pass road; hillsboro OR
• Manufacturer Contact: ellie wood ; 5885 ne cornelius pass rd.; hillsboro, OR
• MDR Report Key: 18637994
• MDR Text Key: 334495566
• Report Number: 3025141-2024-00092
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other